Travoprost Five Day Posology Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TRAVATAN; TRAVATAN 0.004% once daily	Drug: 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
Placebo Comparator: Travoprost Vehicle	Drug: Travoprost Vehicle; 1 drop in each eye 8 times daily for 5 days
Experimental: Travoprost Group A	Drug: Travoprost (Groups A, B and C); 1 drop in each eye 8 times daily for 5 days
Experimental: Travoprost Group B	Drug: Travoprost (Groups A, B and C); 1 drop in each eye 8 times daily for 5 days
Experimental: Travoprost Group C	Drug: Travoprost (Groups A, B and C); 1 drop in each eye 8 times daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5	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	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP Change From Baseline at 8 PM on Day 5	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	5 Days

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: May 26, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: C-09-075