Patient Preference Study

NCT ID: NCT00576342

Last Updated: 2014-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type OTHER

AL-3862+timolol ophthalmic suspension

Intervention Type DRUG

Dorzolamide+timolol ophthalmic solution

Intervention Type DRUG

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.

Group Type OTHER

AL-3862+timolol ophthalmic suspension

Intervention Type DRUG

Dorzolamide+timolol ophthalmic solution

Intervention Type DRUG

Interventions

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AL-3862+timolol ophthalmic suspension

Intervention Type DRUG

Dorzolamide+timolol ophthalmic solution

Intervention Type DRUG

Other Intervention Names

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COSOPT

Eligibility Criteria

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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;

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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C-07-47

Identifier Type: -

Identifier Source: org_study_id

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