Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Subjects.
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 5/5/2014 |
| Start Date: | February 2014 |
| End Date: | April 2014 |
| Contact: | Kris Hartman |
| Email: | kris.hartman@bausch.com |
| Phone: | 585-338-5165 |
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% in a Population of Pediatric, Adult, and Geriatric Subjects.
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025%
versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51%
of subjects will be 40 years of age or older.
versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51%
of subjects will be 40 years of age or older.
Inclusion Criteria:
- Participants must be at least 5 years of age at Visit 1 of either sex gender and any
race or ethnicity;
- Have ocular health within normal limits, including a calculated best- corrected (if
necessary) visual acuity of 0.3 logMAR or better in each eye, as measured using an
Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
Exclusion Criteria:
- Have any ocular/systemic health problems
- Use of any disallowed medications during the period indicated prior to Visit 1 and
for the duration of the study.
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