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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000581-10-GB

Enrollment

100

Registered

2013-04-04

Start date

2013-07-25

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Xalatan Product Name: latanoprost Product Code: N/A Pharmaceutical Form: Eye drops, solution INN or Proposed INN: latanopros

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Ocular surface disease index score;Timepoint(s) of evaluation of this end point: 1, 3, 6, 12 and 24 months	—

Primary

Measure	Time frame
Main Objective: Primary outcome: To evaluate the expression of inflammatory markers in the tear film and on the ocular surface of patients undergoing treatment for glaucoma and ocular hypertension using drops containing different types of preservative or no preservative. Biomarker outcomes: 1.identification of tear, ocular surface and tissue expression of biomarkers of inflammation between patients using preserved and presrveative free medical treatment for glaucoma and the control participants 2.quantification of changes in biomarker expression between different treatment modalities. 3.quantification and identification of profile changes in inflammatory biomarker expression over time and with different drop regimes ; Secondary Objective: Clinical Outcomes: Ocular surface disease index (OSDI) assessment: this is a short questionairre (6 questions) which evaluate the patients ocular surface symptoms Biomarkers outcome evaluation of inflammatory markers on conjunctival cells, Tenons capsule tissue and trabecular meshwork (TMW) cells from tissue samples opportunistically taken at the time of cataract or glaucoma surgery. Secondary outcome: TMW endothelium cell health following exposure to different preservative regimes ;Primary end point(s): Biomarker change on the ocular surface as measured by tear film and impression cytology evaluation;Timepoint(s) of evaluation of this end point: 1, 3, 6, 12 and 24 months	—

Measure

Time frame

Main Objective: Primary outcome: To evaluate the expression of inflammatory markers in the tear film and on the ocular surface of patients undergoing treatment for glaucoma and ocular hypertension using drops containing different types of preservative or no preservative. Biomarker outcomes: 1.identification of tear, ocular surface and tissue expression of biomarkers of inflammation between patients using preserved and presrveative free medical treatment for glaucoma and the control participants 2.quantification of changes in biomarker expression between different treatment modalities. 3.quantification and identification of profile changes in inflammatory biomarker expression over time and with different drop regimes ; Secondary Objective: Clinical Outcomes: Ocular surface disease index (OSDI) assessment: this is a short questionairre (6 questions) which evaluate the patients ocular surface symptoms Biomarkers outcome evaluation of inflammatory markers on conjunctival cells, Tenons capsule tissue and trabecular meshwork (TMW) cells from tissue samples opportunistically taken at the time of cataract or glaucoma surgery. Secondary outcome: TMW endothelium cell health following exposure to different preservative regimes ;Primary end point(s): Biomarker change on the ocular surface as measured by tear film and impression cytology evaluation;Timepoint(s) of evaluation of this end point: 1, 3, 6, 12 and 24 months

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Countries

United Kingdom

Contacts

Public ContactKing

Nottingham University NHS Trust

anthony.king@nuh.nhs.uk0115 9249924 ext 64247

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026