Effect on the eye surface when treating glaucoma with eye drops

Phase 1

• Conditions: glaucoma and ocular hypertension; MedDRA version: 20.0Level: LLTClassification code 10036719Term: Primary open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-001642-18-DK
• Lead Sponsor: Department of Ophthalmology, Rigshospitalet-Glostrup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

a. Age >18years
b. Danish speaking
c. Open angle glaucoma or ocular hypertension
d. Average intraocular pressure equal to or above 22 mmHg based on 3
measurements on each eye
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

a. history of significant eye diseae (including okular trauma) other than
open angle glaucoma and ocular hypertension
b. Pressure difference equal to or above 4 mmHg between eyes
c. corneal thickness <450µm or >600µm
d. treatment with steroids within the last 3 months from inclusion
e. Significant untreated systemic disease such as hypertension, heart
failure, diabetes mellitus, stroke, lung disease and autoimmune
diseases. Diseases are not reason for exclusion if they are well treated or does not need treatment
f. smoker at inclusion
g. pregnant or breast feeding
h. women using unsafe anticonception
i. allergy towards trial medication
j. patients who cannot cooperate in eye examination

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare goblet cell density when treating with a differently<br>preserved travoprost eye drops in each eye;Secondary Objective: To compare eye pressure, ocular surface, tear film and symptoms of dry<br>eyes when treating with a differently preserved travoprost eye drops in<br>each eye;Primary end point(s): Goblet cell density<br>E.5.1.1;Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Intraocular pressure lowering effect<br>Corneal and conjunctival surface<br>Mucin in tear film<br>Symptoms of dry eyes;Timepoint(s) of evaluation of this end point: 4 weeks