Patient Preference Study

NCT00576342 | Completed Phase 3

• 1 other identifier: C-07-47
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a stated preference for either study medication

  Day 2

Secondary Outcomes (1)

• Mean ocular discomfort score

  Day 1, 1 minute after drop instillation

Study Arms (2)

AL-3862+timolol, then COSOPT

OTHER

AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.

Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution

COSOPT, then AL-3862+timolol

OTHER

Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.

Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution

Interventions

AL-3862+timolol ophthalmic suspension DRUG

AL-3862+timolol, then COSOPT; COSOPT, then AL-3862+timolol

Dorzolamide+timolol ophthalmic solution DRUG

Also known as: COSOPT

AL-3862+timolol, then COSOPT; COSOPT, then AL-3862+timolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: December 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 11, 2014

Record last verified: 2014-07