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Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.
Details
| Lead sponsor | Alcon Research |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 105 |
| Start date | 2003-01 |
| Completion | 2006-11 |
Conditions
- Glaucoma
- Ocular Hypertension
Interventions
- BETOPTIC S (betaxolol HCl)
- Timolol Gel-forming Solution (TGFS)
Primary outcomes
- Mean change from baseline in IOP — Up to Week 12
Countries
United States