Phase 3
N=193
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02105285 ↗Enrolled (actual)
193
Serious AEs
0.5%
Results posted
Nov 2015
Primary outcome: Primary: Decrease From Baseline in Intraocular Pressure at Week 8 Predose — 3.5; 1.6 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-1085EL ophthalmic solution (Drug); Carteolol long-acting ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease From Baseline in Intraocular Pressure at Week 8 Predose |
3.5; 1.6 | — |
| SECONDARY Intraocular Pressure at Week 8 Predose |
16.3; 18.2 | — |
| SECONDARY Intraocular Pressure at Week 8 at 2 Hours After IMP Administration |
15.7; 17.8 | — |
| SECONDARY Intraocular Pressure at Week 8 at 8 Hours After IMP Administration |
15.2; 17.9 | — |
| SECONDARY Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration |
2.9; 0.8 | — |
| SECONDARY Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration |
3.0; 0.3 | — |
Summary
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.
Eligibility Criteria
Inclusion Criteria
- Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension
Exclusion Criteria
- Subjects with ocular conditions as defined by the protocol
Data sourced from ClinicalTrials.gov (NCT02105285). 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.