Travoprost Five Day Posology Study

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114893
• Other study ID #: C-09-075
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: May 26, 2011
• Start date: April 2010

Study information

• Verified date: May 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma (OAG)

Intervention

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
• Travoprost Vehicle
1 drop in each eye 8 times daily for 5 days
• Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No