Overview
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2019-12-31
2019-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: - DE-117 Ophthalmic Solution once daily and Vehicle once daily, or - Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Santen Inc.Treatments:
Maleic acid
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Criteria
Inclusion Criteria:• glaucoma or ocular hypertension
Exclusion Criteria:
- Females who are pregnant, nursing, or planning a pregnancy
- Any corneal abnormality or other condition interfering with or preventing reliable
tonometric measurements