Patient Preference Study

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution

• Registration Number: NCT00576342
• Lead Sponsor: Alcon Research

Brief Summary

In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-19
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-09
• Disposition First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Disposition First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Sign informed consent;
• Diagnosis of glaucoma or ocular hypertension;
• On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
• IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
• Pregnant, nursing, or not using highly effective birth control methods;
• Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
• History of bronchial asthma or severe chronic obstructive pulmonary disease;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AL-3862+timolol, then COSOPT	AL-3862+timolol ophthalmic suspension	AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
AL-3862+timolol, then COSOPT	Dorzolamide+timolol ophthalmic solution	AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
COSOPT, then AL-3862+timolol	Dorzolamide+timolol ophthalmic solution	Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.
COSOPT, then AL-3862+timolol	AL-3862+timolol ophthalmic suspension	Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a stated preference for either study medication	Day 2

Secondary Outcome Measures

Name	Time	Method
Mean ocular discomfort score	Day 1, 1 minute after drop instillation