A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 3
- Intervention
- AL-3862+timolol ophthalmic suspension
- Conditions
- Glaucoma
- Sponsor
- Alcon Research
- Enrollment
- 129
- Primary Endpoint
- Percentage of patients with a stated preference for either study medication
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.
Investigators
Eligibility Criteria
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.
Arms & Interventions
AL-3862+timolol, then COSOPT
AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
Intervention: AL-3862+timolol ophthalmic suspension
AL-3862+timolol, then COSOPT
AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
Intervention: Dorzolamide+timolol ophthalmic solution
COSOPT, then AL-3862+timolol
Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.
Intervention: AL-3862+timolol ophthalmic suspension
COSOPT, then AL-3862+timolol
Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.
Intervention: Dorzolamide+timolol ophthalmic solution
Outcomes
Primary Outcomes
Percentage of patients with a stated preference for either study medication
Time Frame: Day 2
Secondary Outcomes
- Mean ocular discomfort score(Day 1, 1 minute after drop instillation)