What Is the Purpose of Baby Shampoo Eye Scrubs?
Medicine (Baltimore). 2020 May; 99(19): e20155.
Efficacy of baby shampoo and commercial eyelid cleanser in patients with meibomian gland dysfunction
A randomized controlled trial
Monitoring Editor: Juan Carlos Serna-Ojeda.
Received 2019 Sep 19; Revised 2020 Feb ten; Accustomed 2020 Apr iv.
Abstract
Groundwork:
To compare the efficacy betwixt Johnson's baby shampoo acme-to-toe (No More Tears formula) and OCuSOFT Chapeau Scrub Original Foaming Eyelid Cleanser (OSO) in patients with grade 2 meibomian gland dysfunction (MGD).
Methods:
Sixty participants with grade ii MGD were enrolled and analyzed based on intention to treat basis in a prospective, randomized, single-blind trial for eye scrub using either diluted baby shampoo or OSO. The data collection included the Ocular Surface Disease Alphabetize (OSDI) questionnaire, compliance, and complications. The eye examinations were according to the Tear Motion picture and Ocular Surface Guild at baseline and at post-treatment weeks 4 and 12.
Results:
The mean (±SD) historic period of the 60 patients who presented with course ii MGD was 48.0 ± 13.8 years and 75.0% were females. The OSDI scores of these participants betwixt pre-handling and mail service-handling weeks iv and 12 improved significantly in both groups (all P < .001). The mean (±SD) differences of the improvement of OSDI score from baseline were non statistically significantly different between the baby shampoo and OSO groups at mail service-treatment weeks 4 and 12 (P = .57 and P = .54, respectively). The compliance and complications were as well not statistically meaning between the 2 groups.
Conclusions:
Eyelid scrub using either baby shampoo or OSO and warm compresses could significantly reduce eye irritability and uncomfortable symptoms in class 2 MGD patients. In this study, the efficacy, compliance, and complications between the 2 groups were not statistically significantly different.
Keywords: baby shampoo, dry out heart, meibomian gland dysfunction, OCuSOFT hat scrub original
1. Introduction
Meibomian glands are a special kind of sebaceous gland located in the tarsal plate of the upper and lower eyelids. Lipids are produced by the meibomian glands, which are the main components of the superficial lipid layer of the tear moving picture that protects against evaporation of the aqueous stage and stabilizes the tear film. Hence, meibomian lipids are essential for the maintenance of ocular surface health and integrity.[i] Meibomian gland dysfunction (MGD) is an extremely important condition and is 1 of the virtually common causes of dry out heart.[2–4] Previous studies reported that the prevalence of MGD amid Caucasians varied from 3.5% to 19.9%.[5,half dozen] In the Asian population, the prevalence of MGD was higher and varied betwixt 46.2% and 69.3%.[7–10] A Bangkok population-based report reported that 46.2% of Thais had MGD and 63.6% of people with dry out eye had MGD.[7]
Co-ordinate to the Tear Film and Ocular Surface Society (TFOS) grading organisation, the treatment guideline depends on the severity of the MGD. These guidelines consider symptoms and clinical signs of gland expression, meibum quality, ocular surface staining, and lid margin. The management of MGD according to the International Workshop on MGD reached a consensus that eyelid hygiene is the mainstay of clinical treatment of MGD, which consists of 2 components: warm compresses and lid hygiene, including scrubs and mechanical expression.[11] A published study showed that the use of hypoallergenic bar soap, diluted baby shampoo, and commercial eyelid cleanser were useful in the treatment of MGD.[12] However, the efficacy of baby shampoo in the management of MGD is controversial. The electric current literature shows a lack of standard handling of lid hygiene and no data are bachelor on patient compliance with MGD. The efficacy of hypoallergenic bar soap was not investigated in our study because it is available only at drug stores, additionally; information technology is not a commercial product for eyelid scrub. Although, baby shampoo is not a special substance for eyelid scrub, it is widely available. The efficacy of baby shampoo is possibly equivalent to OCuSOFT Chapeau Scrub Original Foaming Eyelid Cleanser (OSO) in class ii MGD treatment.
The master objective of the investigation was to appraise and compare the effects of eyelid cleaning using either a defended eyelid cleanser (OSO, Rosenberg, TX) or Johnson's infant shampoo top-to-toe (No More Tears formula, Johnson & Johnson, Thailand)[13] to decrease the symptomatology of dry eye sufferers with grade ii MGD (Table 1).
Table 1
Ingredients of Johnson'southward babe shampoo elevation-to-toe (No More than TearsTM formula) and a commercial eyelid cleanser, OCuSOFT lid scrub original foaming eyelid cleanser (OSO).
two. Methods
two.1. Written report design
This prospective study was conducted at Songklanagarind Infirmary, Prince of Songkla Academy, Thailand. The study adhered to the tenets of the Declaration of Helsinki and was approved by the Homo Inquiry Ideals Committee of the Faculty of Medicine, Prince of Songkla University. The Thai Clinical Trials Registry Number was TCTR20160726001. Informed consent was obtained from the subjects afterwards explanation of the nature and possible consequences of the study.
2.2. Discipline eligibility
The study enrolled participants from 25 to 70 years of age from the out-patient eye clinic in Songklanagarind Hospital from July 2016 to September 2017. All participants were diagnosed with grade 2 MGD according to the TFOS guideline because nosotros could eliminate the confounding factors (e.one thousand., oral tetracycline derivative and anti-inflammatory therapy) affecting the MGD treatment outcome. The participants were able to follow a scheduled visit and use a microwave at home. Informed consent was taken from all participants before participation. The subjects were excluded if whatsoever of the following presented in the study: cicatricial eyelid diseases or conjunctival diseases that affect ocular signs and symptoms (for case, pterygium), recent ocular trauma, any corneal lesions or other meibomian gland diseases (for case, meibomian seborrhea or meibomian sicca), following heart or periocular surgery, current use of facial topical antibiotics, history of allergy to cosmetics, any composition of cosmetics or history of allergy to babe shampoo, or any limerick of shampoo.
2.three. Study protocol
After classification into the level of severity, all 60 participants with grade 2 MGD were randomized for eyelid scrub using baby shampoo or OSO by cake-of-iv figurer randomizations. The allocation ratio was 1:ane, and the randomization was performed per discipline and the sequence of randomization was curtained from all investigators by sealed envelopes. The participants in the babe shampoo group were instructed to employ a 1:one mixture of baby shampoo[12] and clean water to scrub into the eyelid for thirty to 60 seconds then rinse. The participants in the OSO group were instructed to employ OCuSOFT hat scrub original foaming eyelid cleanser to scrub the eyelid for 30 to 60 seconds and then rinse. Product applications were demonstrated by the same investigator at the enrollment visit. All participants in both groups received written instructions and also a heated rice handbag delivered 40 to 42°C heat to the eyelids for 5 minutes earlier performing the eyelid scrub (application 2 times/day).
2.iv. Outcome measures and follow-up evaluations
The primary effect mensurate was to compare the mean (±SD) differences of the improvement of Ocular Surface Disease Index (OSDI) score from baseline to weeks 4 and weeks 12 post-treatment, between baby shampoo and OSO. The secondary outcome measures were chapeau margin signs co-ordinate to the TFOS guideline, times of compliance, and the percentage of complications.
At the initial visit, history and demographic information of all participants were nerveless that included age, sex, underlying illness, medication profile, history of drug, or any cosmetic ingredient allergy. The participants were evaluated by best-corrected visual acuity (BCVA) measured by the early treatment diabetic retinopathy study chart and later on converted to LogMAR (logarithm of the minimum angle of resolution), OSDI questionnaire adult by the Outcomes Research Grouping at Allergan (Irvine, CA), and MGD grading nether slit lamp biomicroscopy. Other evaluations were meibum quality, expressibility of the glands, corneal staining with fluorescein, and chapeau margin according to the TFOS guideline at enrollment. One investigator (OA), who was masked to the treatment and randomization, performed the follow-up at four and 12 weeks after starting the treatment. Compliance was measured at 4 and 12 weeks past filling out a self-reported form. The participants were instructed to sign the grade every day in the morning and evening (ii times/day) and render the course to the investigator at the follow-up visit.
ii.5. Sample size
Based on a previous study,[14] every bit an eighty% power was used to show non-inferiority (δ = 11) of baby shampoo against OSO as pregnant (for the two-sided five% level) given an SD of 16 and no deviation expected in mean scores of the 2 treatments at 2 times, a sample size of 27 patients per grouping was required. Allowing for unexpected 10% dropout rate, we enrolled 30 patients per grouping in this study.
ii.6. Statistical analysis
Information were analyzed using Stata Statistic Software (STATA MP 14.1. StataCorp LP). Data analysis was based on intention to treat basis. Descriptive statistics using mean and standard difference were reported at each visit. The repeated measures of OSDI scores were evaluated. For the principal outcome, the total scores of the OSDI questionnaire were compared between the 2 groups using the independent samples test. The mean OSDI score in baby shampoo and OSO by week was evaluated using mixed model linear regression. The times of compliance were compared between the 2 groups using the independent samples test. The differences between the two treatments in hat margin signs according to the TFOS guideline were compared using the Pearson chi-foursquare test. A P value <.025 was considered statistically significant.
iii. Results
3.1. Report pick
A total of 60 participants diagnosed with form two MGD were enrolled and completed the assay. 60-five percent of the participants had a Bachelor's caste or college and 75.0% was females. The mean (±SD) historic period was 48.0 ± thirteen.8 years (range 25–lxx years). The participants were randomized into either the babe shampoo group (50%) or the OSO group (fifty%) (Table 2). Effigy 1 illustrates the flow of participants through the written report co-ordinate to the Consolidated Standards of Reporting Trials (CONSORT) requirements.
Table 2
Baseline clinical characteristics of threescore participants.
Flow diagram co-ordinate to the Consolidated Standards of Reporting Trials (Espoused) statement, showing recruitment, randomization, and patient flow in this study. OSO, OCuSOFT Hat Scrub Original Foaming Eyelid Cleanser.
iii.2. OSDI and handling outcome in ii groups
The OSDI scores in the baby shampoo grouping and OSO grouping prior to handling were 42.6 ± 16.1 and 42.1 ± fourteen.0, respectively. The OSDI scores, BCVA, and compliance of all participants were recorded. Three participants per grouping were lost to follow-upwards, prior to week four, post-handling follow-upward. According to the TFOS international workshop on MGD, 54 participants were examined under slit lamp biomicroscopy and the parameters at weeks 4 and weeks 12 mail-treatment are presented in Table 3.
Tabular array 3
OSDI score, visual acuity, and parameters according to the TFOS guideline at 4 wk, and at 12 wk postal service-treatment.
In that location was a pregnant improvement in the OSDI score at post-treatment week 4 (20.3 ± 10.3 [95% confidence interval 16.1, 24.5] in infant shampoo and 17.9 ± 9.eight [95% confidence interval xiii.7, 22.1] in OSO) compared with baseline (both P < .001). This improvement was significant at post-treatment week 12 in both the baby shampoo and OSO groups (12.0 ± half-dozen.six [95% confidence interval 7.eight, 16.two] and 9.five ± 4.7 [95% confidence interval five.3, 13.seven], respectively, both P < .001) (Fig. 2). All the same, no difference was plant between the two groups at either post-handling week 4 (P = .57) or mail-treatment week 12 (P = .54) using mixed model linear regression. The mean (±SD) compliance results of eyelid scrub for the total of 12 weeks were 125.1 ± 20.8 and 124.half-dozen ± sixteen.eight times (from a total of 168 times at 2 times/day in 84 days) in the baby shampoo and OSO groups, respectively (P = .93). The baseline OSDI scores were non correlated with compliance at calendar week 4 in the baby shampoo and OSO groups (P = .68 and P = .29, respectively).
Mean differences of OSDI scores at baseline, 4 wk, and 12 wk. ∗ P < .001, subtract in the OSDI scores from baseline to 4-wk post-treatment. ∗∗ P < .001, decrease in the OSDI scores from 4-wk to 12-wk postal service-treatment. OSO, OCuSOFT Hat Scrub Original Foaming Eyelid Cleanser.
3.three. Complications
Complications in both treatments are shown in Table 4. At that place were no differences at four and 12 weeks between the ii groups in complications that included eye irritation, burning awareness, trigger-happy, photophobia, blurred vision, carmine eye, and skin or eyelid erythema (all P ≥ .05).
Tabular array 4
Complications of both treatments.
4. Discussion
Dry out eye is a multifactorial illness of tears and the ocular surface which is associated with MGD that results in symptoms of discomfort, visual disturbance, and an unstable tear pic with potential damage to the ocular surface, which affects quality of life.[xv–17] Information technology is accompanied by increased osmolarity of the tear picture and inflammation of the ocular surface.[xviii] Eyelid hygiene and warm compresses are the mainstay treatments for MGD; however, clinicians employ a wide range of treatment regimens to manage MGD.[19,xx]
In this randomized trial, significant comeback was observed in the OSDI scores subsequently using either the baby shampoo or the OSO in course two MGD patients at weeks 4 and weeks 12 mail service-handling. Although this current study showed an improvement in the number of secondary outcomes including meibum quality, expressibility, and ocular staining in both groups, there were no statistically pregnant differences between the 2 groups. To our knowledge, eyelid scrub should statistically significantly amend the symptom scores; however, no meaning comeback in the chapeau margin signs was observed in either treatment because simply grade 2 MGD was selected. Information technology was reported that in moderate to advanced MGD patients who were treated with intense pulsed light had pregnant comeback of eyelid signs.[21]
These findings are consistent with previous reports which described improvements in MGD or the signs and symptoms of blepharitis following eyelid hygiene regimens with dedicated eyelid scrub and diluted baby shampoo.[12,14,22–24] Patients who used a phospholipid–liposome solution specially designed for hat scrub demonstrated a significantly greater clinical improvement than those who used a mild baby shampoo.[23] Sung et al demonstrated the objective and subjective clinical improvements in blepharitis patients post-obit a four-week treatment with both a defended eyelid cleanser (TheraTears Sterilid) and a diluted baby shampoo at a ratio of 1:10.[25] The results revealed significant comeback in the Standardized Patient Evaluation of Center Dryness questionnaire and Symptom Assessment in Dry Heart (SANDE) symptomology scores; all the same, the SANDE score in eyelid cleanser treatment had significantly greater improvement.[25] In a previous written report, the SANDE questionnaire had a significant correlation and negligible score differences in the OSDI scores.[26] Interestingly, in this study the baby shampoo group had a non-junior outcome compared with a previous report.[25] Starting time, the concentration of baby shampoo and water at a ratio of i:i was college which was perhaps more than effective in eyelid scrub. Second, the formulation of baby shampoo in our written report was without yellow 6 and yellow 10. Third, just participants who had grade two MGD without blepharitis were included, which is a low-form severity of MGD. Sung et al likewise reported a significant reduction in matrix metallopeptidase 9 expression in the dedicated eyelid cleanser group, in addition to, decreased goblet cells and MUC5AC expression in the baby shampoo grouping which was maybe from the detergent effects.[25]
In addition, the comparing between the 2 groups plant no statistically significant differences in the improvements of the OSDI scores likewise as the clinical signs that included hat margin, meibum quality, expressibility, and ocular staining. The participants in our study understood and followed our instructions to perform the eyelid scrub properly with overall expert compliance in both handling groups. However, the real state of affairs in the outpatient dispensary of a self-applied therapy is limited by patient compliance.
Encouraging long-term utilize of eyelid hygiene and warm compresses presents a claiming for the ophthalmologist. The introduction of eyelid scrubbing methods, such equally OSO and diluted babe shampoo, may provide a more than consistent solution for compliance. This study showed that the mean (±SD) compliances were 125.ane ± 20.8 and 124.6 ± 16.8 times in the baby shampoo and OSO groups, respectively, which had no statistically meaning deviation between the two groups (P = .93). Additionally, the effectiveness of any self-applied treatment depends on patient preference, efficacy sensation, convenience, ease of purchase, cost, and any adverse effects. All participants used the baby shampoo for eyelid scrub, which was conducted with unsterile tap water and lathered the foam conception by on their own. The efficacy, compliance, and complications in the babe shampoo group were not significantly different from the OSO group.
The strong indicate of this electric current study is the unique participants who were grade 2 MGD and therefore the confounding factors affecting the MGD treatment upshot could be eliminated. The result revealed that the diluted infant shampoo is one of the options for handling of eyelid scrub in grade 2 MGD patients. The baby shampoo is available in the convenience store and depression price (1 $/bottle). In contrast, OSO is express to purchase in some rural area and high toll (eleven–17 $/bottle). The outcomes from our written report tin can provide more than data on eyelid cleaning methods in Thai patients and perhaps for the worldwide population to develop a standardized technique in eyelid cleaning for patients with MGD.
5. Limitations
Our study had some limitations every bit followings. First, we could not blind the participants because the packages of the 2 eyelid scrubbing methods were unlike. However, nosotros could blind the investigator who evaluated the clinical parameters of the participants. 2d, we did non mensurate the conjunctival cytology, which might need a further report to prove the results in patients with course 2 MGD.
6. Conclusions
In summary, this study showed that either OSO or infant shampoo for eyelid scrub tin better the dry out eye symptoms scores for patients with class 2 MGD fifty-fifty though there was no statistically meaning divergence between the two groups. The compliance and complication results were also non statistically significantly difference between the 2 groups and no serious agin events were reported.
Acknowledgments
We would like to thank Dr. Alan Geater, Ms. Walailuk Jitphiboon, and Ms. Parichat Damthongsuk for her valuable assistance regarding the statistics used in this project.
Writer contributions
Study concept and design: OA and YU; Acquisition of information: OA, YU, PS, and OH; Assay and interpretation of data: OA, YU, PS, and OH; Drafting the manuscript: OA and YU; Revising the manuscript critically for important intellectual content: OA, YU, PS, and OH; Study supervision: OA, PS, and OH. All authors had full access to all of the data in this report and take responsibility for the integrity of the information and the accurateness of the data analysis. All authors read and approved the final manuscript.
Footnotes
Abbreviations: MGD = meibomian gland dysfunction, OSDI = Ocular Surface Disease Index, OSO = OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser.
How to cite this article: Aryasit O, Uthairat Y, Singha P, Horatanaruang O. Efficacy of baby shampoo and commercial eyelid cleanser in patients with meibomian gland dysfunction: a randomized controlled trial. Medicine. 2020;99:19(e20155).
OA and YU have received grants from Faculty of Medicine, Prince of Songkla University. The funding organization had no role in the study design or conduct of this enquiry.
Ethics approving was provided past the Ethics Committee, Faculty of Medicine, Prince of Songkla University (The Thai Clinical Trials Registry Number was TCTR20160726001).
Informed consent was obtained from all private participants included in the study.
The authors have no conflicts of interest to disclose.
The datasets generated during and/or analyzed during the current study are publicly available.
References
[1] Knop East, Knop N, Millar T, et al. The international workshop on meibomian gland dysfunction: study of the subcommittee on anatomy, physiology and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci 2011;52:1938–78. [PMC free article] [PubMed] [Google Scholar]
[ii] Nichols KK, Foulks GN, Bron AJ, et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci 2011;52:1922–9. [PMC complimentary article] [PubMed] [Google Scholar]
[3] Qiao J, Yan X. Emerging treatment options for meibomian gland dysfunction. Clin Ophthalmol 2013;7:1797–803. [PMC free article] [PubMed] [Google Scholar]
[iv] Bron AJ, Tiffany JM. The contribution of meibomian illness to dry eye. Ocul Surf 2004;two:149–65. [PubMed] [Google Scholar]
[v] Schein OD, Munoz B, Tielsch JM, et al. Prevalence of dry eye amid the elderly. Am J Ophthalmol 1997;124:723–eight. [PubMed] [Google Scholar]
[6] McCarty CA, Bansal AK, Livingston PM, et al. The epidemiology of dry heart in Melbourne, Australia. Ophthalmology 1998;105:1114–9. [PubMed] [Google Scholar]
[7] Lekhanont Grand, Rojanaporn D, Chuck RS, et al. Prevalence of dry middle in Bangkok, Thailand. Cornea 2006;25:1162–vii. [PubMed] [Google Scholar]
[8] Lin PY, Tsai SY, Cheng CY, et al. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology 2003;110:1096–101. [PubMed] [Google Scholar]
[9] Uchino Thousand, Dogru Yard, Yagi Y, et al. The features of dry middle affliction in a Japanese elderly population. Optom Vis Sci 2006;83:797–802. [PubMed] [Google Scholar]
[10] Jie Y, Xu 50, Wu YY, et al. Prevalence of dry eye among adult Chinese in the Beijing Centre Study. Eye (Lond) 2009;23:688–93. [PubMed] [Google Scholar]
[11] Geerling 1000, Tauber J, Baudouin C, et al. The International Workshop on Meibomian Gland Dysfunction: report of the subcommittee on direction and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci 2011;52:2050–64. [PMC gratuitous article] [PubMed] [Google Scholar]
[12] Fundamental JE. A comparative study of eyelid cleaning regimens in chronic blepharitis. CLAO J 1996;22:209–12. [PubMed] [Google Scholar]
[14] Guillon One thousand, Maissa C, Wong S. Symptomatic relief associated with eyelid hygiene in anterior blepharitis and MGD. Center Contact Lens 2012;38:306–12. [PubMed] [Google Scholar]
[15] Duncan K, Jeng BH. Medical management of blepharitis. Curr Opin Ophthalmol 2015;26:289–94. [PubMed] [Google Scholar]
[16] Buchholz P, Steeds CS, Stern LS, et al. Utility assessment to measure the impact of dry center disease. Ocul Surf 2006;four:155–61. [PubMed] [Google Scholar]
[17] Koh S, Ikeda C, Fujimoto H, et al. Regional differences in tear film stability and meibomian glands in patients with aqueous-deficient dry eye. Heart Contact Lens 2016;42:250–5. [PubMed] [Google Scholar]
[18] The definition and classification of dry out eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop. Ocul Surf 2007;5:75–92. [PubMed] [Google Scholar]
[nineteen] Lee 50, Garrett Q, Flanagan JL, et al. Treatment practices and outcomes of meibomian gland dysfunction at a tertiary center in Southern India. Centre Contact Lens 2018;44:S138–43. [PubMed] [Google Scholar]
[20] Lee H, Kim Thousand, Park SY, et al. Mechanical meibomian gland squeezing combined with eyelid scrubs and warm compresses for the handling of meibomian gland dysfunction. Clin Exp Optom 2017;100:598–602. [PubMed] [Google Scholar]
[21] Albietz JM, Schmid KL. Intense pulsed light handling and meibomian gland expression for moderate to advanced meibomian gland dysfunction. Clin Exp Optom 2018;101:23–33. [PubMed] [Google Scholar]
[22] Lindsley K, Matsumura S, Hatef Eastward, et al. Interventions for chronic blepharitis. Cochrane Database Syst Rev 2012;CD005556.DOI 101002/14651858.CD005556.pub2. [PMC free article] [PubMed] [Google Scholar]
[23] Khaireddin R, Hueber A. Eyelid hygiene for contact lens wearers with blepharitis. Comparative investigation of handling with infant shampoo versus phospholipid solution. Ophthalmologe 2013;110:146–53. [PubMed] [Google Scholar]
[24] Arrua M, Samudio K, Farina Due north, et al. Comparative study of the efficacy of different treatment options in patients with chronic blepharitis. Arch Soc Esp Oftalmol 2015;90:112–eight. [PubMed] [Google Scholar]
[25] Sung J, Wang MTM, Lee SH, et al. Randomized double-masked trial of eyelid cleansing treatments for blepharitis. Ocul Surf 2018;16:77–83. [PubMed] [Google Scholar]
[26] Amparo F, Schaumberg DA, Dana R. Comparison of two questionnaires for dry middle symptom assessment: the ocular surface disease index and the symptom assessment in dry center. Ophthalmology 2015;122:1498–503. [PMC free commodity] [PubMed] [Google Scholar]
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220370/
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