Travoprost Five Day Posology Study

NCT ID: NCT01114893

Last Updated: 2011-06-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.

Detailed Description

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Conditions

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Open-angle Glaucoma (OAG) 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 0.004% once daily

Group Type ACTIVE_COMPARATOR

Travoprost 0.004%

Intervention Type DRUG

1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days

Travoprost Vehicle

Travoprost Vehicle

Group Type PLACEBO_COMPARATOR

Travoprost Vehicle

Intervention Type DRUG

1 drop in each eye 8 times daily for 5 days

Travoprost Group A

Travoprost Group A

Group Type EXPERIMENTAL

Travoprost (Groups A, B and C)

Intervention Type DRUG

1 drop in each eye 8 times daily for 5 days

Travoprost Group B

Travoprost Group B

Group Type EXPERIMENTAL

Travoprost (Groups A, B and C)

Intervention Type DRUG

1 drop in each eye 8 times daily for 5 days

Travoprost Group C

Travoprost Group C

Group Type EXPERIMENTAL

Travoprost (Groups A, B and C)

Intervention Type DRUG

1 drop in each eye 8 times daily for 5 days

Interventions

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Travoprost 0.004%

1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days

Intervention Type DRUG

Travoprost Vehicle

1 drop in each eye 8 times daily for 5 days

Intervention Type DRUG

Travoprost (Groups A, B and C)

1 drop in each eye 8 times daily for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. either sex and any race/ethnicity, ≥18 years old
2. diagnosed with open-angle glaucoma, and/or ocular hypertension
3. meets the following IOP entry criteria:

* Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
* Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
4. satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria

1. females of childbearing potential not meeting protocol conditions
2. angle grade less than Grade 2 in either eye
3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
4. severe central visual field loss in either eye
5. any abnormality preventing reliable applanation tonometry in either eye
6. hypersensitivity to prostaglandin analogues or to any component of the study medication
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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Alcon Research, Ltd

Locations

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Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-09-075

Identifier Type: -

Identifier Source: org_study_id

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