Examining the effects of eye drops on changes in inflammation on the surface of the eye

Phase 1

• Conditions: Glaucoma is the condition that is being treated by these eye drops - however the study is aimed at measuring the amount of inflammation that develops on the surface of the eye when these drops are used; MedDRA version: 14.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-000581-10-GB
• Lead Sponsor: ottingham University NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-04
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Presentation with glaucoma in at least one eye. (not for control group)
Willingness to have tear samples and impression cytology performed
Willingness to have Tenons and conjunctival biopsy performed if glaucoma or cataract surgery performed.
Willingness to have trabecular meshwork and iris samples evaluated if undergoing glaucoma surgery
No other known ocular surface disease (apart from mild dry eye or blepharitis).
Age over 18 years

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

Unable or ineligible to provide informed consent
History of ocular surface disease (apart from dry eye or blepharitis)
Active use of topical eye drops apart from ocular lubricants

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified