A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00333125

Last Updated: 2016-11-18

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

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and safety of two combination products in patients with open-angle glaucoma or ocular hypertension.

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Travoprost/Timolol

Group Type EXPERIMENTAL

Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)

Intervention Type DRUG

One drop in the study eye(s) once daily, 9 PM, for 6 weeks

Timolol Vehicle

Intervention Type OTHER

One drop in the study eye(s) once daily for 6 weeks

Dorzolamide/Timolol

Group Type ACTIVE_COMPARATOR

Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)

Intervention Type DRUG

One drop in the study eye(s) twice daily for 6 weeks

Interventions

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Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)

One drop in the study eye(s) once daily, 9 PM, for 6 weeks

Intervention Type DRUG

Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)

One drop in the study eye(s) twice daily for 6 weeks

Intervention Type DRUG

Timolol Vehicle

One drop in the study eye(s) once daily for 6 weeks

Intervention Type OTHER

Other Intervention Names

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DuoTrav Cosopt

Eligibility Criteria

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Inclusion Criteria

* 18 or older.
* Diagnosis of glaucoma or ocular hypertension.

Exclusion Criteria

* Under 18.
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

References

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Saeed M, Kadir S, Kaufman SL, Murray RR, Milligan F, Cotton PB. Bleeding following endoscopic sphincterotomy: angiographic management by transcatheter embolization. Gastrointest Endosc. 1989 Jul-Aug;35(4):300-3. doi: 10.1016/s0016-5107(89)72796-6.

Reference Type RESULT
PMID: 2788589 (View on PubMed)

Other Identifiers

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C-05-25

Identifier Type: -

Identifier Source: org_study_id

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