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Blepharitis

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

Sponsored by University of Plymouth

About this trial

Last updated 3 years ago

Study ID

SoHP_DO_05

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 60 Years
All
All

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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.

No

Exclusion Criteria

- 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 examiner (inadequate compliance, change in the medical condition, as a result, the exclusion criterion is fulfilled)

- 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.

Locations

Location

Status

Recruiting