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Short-term Effects on Tear Film (Baby Shampoo vs Blephasol)

NCT04858113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-09

No results posted yet for this study

Summary

Lid cleansing is the standard regime that is recommended for the management of blepharitis in the UK and beyond. Whilst many successful commercial preparations exist, and some with clinical evidence, professional guidelines (UK Royal College of Ophthalmologists, UK College of Optometrists, AAO, etc.) continue to advocate the use of a diluted solution of baby shampoo, despite no clinical evidence of its safety, tolerance or long term effectiveness, and despite a statement form the manufacturers that it should not be used for this purpose. Where licensed, registered products exist it seems bizarre that we have this situation, but a Cochrane review from 2012 indicated that only a longitudinal, randomized controlled trial against baby shampoo would alter their conclusions. Whilst that sort of clinical study is possible, it is proposed here to start with a short-term study to look at the immediate changes induced in the tear film and ocular surface when comparing baby shampoo with Blephasol solution, in a blind, randomized controlled trial.

Conditions

  • Blepharitis

Interventions

OTHER

Blephaclean

Blephaclean wipes are used to help treat symptoms of blepharitis (eyelid inflammation) which is commonly associated with dry eye disease and meibomian gland dysfunction.

OTHER

Baby Shampoo

Conventional baby shampoo

Sponsors & Collaborators

  • University of Plymouth

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-10-01
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858113 on ClinicalTrials.gov