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

NCT04858113 | Unknown DMC

• 1 other identifier: SoHP_DO_05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• NIKBUT

  Non-invasive break up time

  1 day

Study Arms (3)

Baby Shampoo

PLACEBO COMPARATOR

Conventional Baby shampoo

Other: Baby Shampoo

No intervention

NO INTERVENTION

Baseline condition without intervention

Blephaclean

EXPERIMENTAL

Intervention

Other: Blephaclean

Interventions

Blephaclean OTHER

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

Blephaclean

Baby Shampoo OTHER

Conventional baby shampoo

Baby Shampoo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be over 18 and under 60 years of age
• Completed a comprehensive eye exam in the last two years
• Contact lens wearers must have stopped wearing for a minimum of two days if wearing soft contact lenses and one week if wearing RGP lenses.
• The subject must have an adequate understanding of the English language to be able to comprehend the oral and written instructions.

You may not qualify if:

• Determination during enrolment:
• Pregnancy or breast-feeding whilst the examination
• Application of any eye drops within the last 48 hours before the examination
• Application of medication within the last 30 days which influences the body water regulation system (e.g. antidepressants, diuretics, corticosteroids, histamine-receptor antagonist, immune-modulators)
• Change of ocular therapy within the last 30 days before the examination
• Permanent application of eye drops or ocular medication
• On-going ocular treatment
• Any kind of ocular pathology or history of refractive surgery
• Any kind of systemic disease which affect collagen and the body water regulation system (Marfan syndrome, osteogenesis imperfect, pseudoxanthoma elasticum, Ehlers-Danlos, diabetes, rosacea, acne, cardiovascular disease, thyroid disease)
• Early termination of the study:
• Drop-out: active termination (decision made by the test person)
• Decision made by the lead investigator/ sponsors
• It is possible to withdraw the participation in the study at any time. The participant is not liable to give any reasons for withdrawing. If the study is withdrawn because of the decision of the investigator, the reasons must be given in the screening form.

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (1)

University of Plymouth

Plymouth, Devon, PL68AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

Daniela Oehring, PhD

CONTACT

+44 (0) 1752 587 547; daniela.oehring@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: October 1, 2018
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)