EUCTR2013-000581-10-GB
Active, not recruiting
Phase 1
Evaluation of inflammatory markers in patients on topical anti-glaucoma drop therapy; a comparative trial of preserved and non-preserved primary medical treatment (eye drops) in patients with glaucoma and ocular hypertension – a pilot study. - Evaluation of ocular surface inflammation with glaucoma drops
ottingham University NHS Trust0 sites100 target enrollmentApril 4, 2013
ConditionsGlaucoma 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 usedMedDRA version: 14.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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
- Sponsor
- ottingham University NHS Trust
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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