Phase 2
N=123
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Primary Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01062971 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Intraocular Pressure (IOP) — 24.1; 23.6; 13.9; 16.9 mmHg — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dorzolamide-timolol-brimonidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) |
24.1; 23.6; 13.9; 16.9 | 0.001 sig |
| SECONDARY Number of Adverse Events |
2; 6 | >0.05 |
Summary
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Eligibility Criteria
Inclusion Criteria
- Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
- Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).
Exclusion Criteria
- Clinically relevant ophthalmic or systemic conditions may be excluded.
Data sourced from ClinicalTrials.gov (NCT01062971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.