Patient Preference Study

A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution; Other Names: COSOPT
Other: 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.	Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution; Other Names: COSOPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with a stated preference for either study medication	Day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean ocular discomfort score	Day 1, 1 minute after drop instillation

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 17, 2007
• First Submitted That Met QC Criteria: December 17, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Pharmaceutical Solutions; Timolol; Dorzolamide; Ophthalmic Solutions
• Other Study ID Numbers: C-07-47