Ocular Hypertension Clinical Trial
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 |
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Contact Alcon Call Center For Trial Locations | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
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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