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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01114893
Other study ID # C-09-075
Secondary ID
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. completion date
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


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
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