Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00471068

Last Updated: 2012-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Detailed Description

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Conditions

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Open-angle 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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Travatan

Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Group Type EXPERIMENTAL

Travatan

Intervention Type DRUG

Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Placebo (Timolol Vehicle)

Intervention Type DRUG

Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Cosopt

treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Group Type ACTIVE_COMPARATOR

Cosopt

Intervention Type DRUG

treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Interventions

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Travatan

Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Intervention Type DRUG

Cosopt

treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Intervention Type DRUG

Placebo (Timolol Vehicle)

Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria

* By Age
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

Principal Investigators

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Anna Grau

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Coimbra

Coimbra, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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EMD-05-03

Identifier Type: -

Identifier Source: org_study_id

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