Patient Preference Study

Alcon

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576342

C-07-47

Details and patient eligibility

About

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

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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129 participants in 2 patient groups

AL-3862+timolol, then COSOPT

Other group

Description:

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

Treatment:

Drug: AL-3862+timolol ophthalmic suspension

Drug: Dorzolamide+timolol ophthalmic solution

COSOPT, then AL-3862+timolol

Other group

Description:

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

Treatment:

Drug: AL-3862+timolol ophthalmic suspension

Drug: Dorzolamide+timolol ophthalmic solution