Travoprost Five Day Posology Study

Phase 2

Completed

• Conditions: Open-angle Glaucoma (OAG); Ocular Hypertension
• Interventions: Drug: Travoprost 0.004%; Drug: Travoprost (Groups A, B and C); Drug: Travoprost Vehicle

• Registration Number: NCT01114893
• Lead Sponsor: Alcon Research

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-04-30
• Primary Completion: 2010-05
• Study First Posted: 2010-05-03
• Status Verified: 2011-05
• Results First Submitted: 2011-05-26
• Results First Submitted QC: 2011-05-26
• Last Update Submitted: 2011-05-26
• Results First Posted: 2011-06-23
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAVATAN	Travoprost 0.004%	TRAVATAN 0.004% once daily
Travoprost Group B	Travoprost (Groups A, B and C)	Travoprost Group B
Travoprost Group C	Travoprost (Groups A, B and C)	Travoprost Group C
Travoprost Vehicle	Travoprost Vehicle	Travoprost Vehicle
Travoprost Group A	Travoprost (Groups A, B and C)	Travoprost Group A

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5	5 days	Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment

Secondary Outcome Measures

Name	Time	Method
IOP Change From Baseline at 8 PM on Day 5	5 Days	Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States