Status:
UNKNOWN
Short-term Effects on Tear Film (Baby Shampoo vs Blephasol)
Lead Sponsor:
University of Plymouth
Conditions:
Blepharitis
Eligibility:
All Genders
18-60 years
Phase:
NA
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, ...
Detailed Description
Aims/Key Questions: The hypothesis is: Diluted baby shampoo is more disruptive and deleterious to the human tear film and ocular surface than Blephaclean solution. It is expected that there will be a ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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 If the study is withdrawn because of the decision of the investigator, the reasons must be given in the screening form.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04858113
Start Date
October 1 2018
End Date
December 31 2023
Last Update
November 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Plymouth
Plymouth, Devon, United Kingdom, PL68AA