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 3 Study

Santen

Status and phase: Completed; Phase 3

Conditions: Glaucoma and Ocular Hypertension

Treatments: Drug: DE-117 Ophthalmic Solution; Drug: Timolol Maleate Ophthalmic Solution 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03691649

011709IN

Details and patient eligibility

About

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. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 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 and will provide additional safety data through Month 12 for subjects receiving DE-117.

Enrollment: 426 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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426 participants in 2 patient groups

DE-117 Ophthalmic Solution

Experimental group

Description:

Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Treatment:

Drug: DE-117 Ophthalmic Solution

Timolol Maleate Ophthalmic Solution 0.5%

Active Comparator group

Description:

Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Treatment:

Drug: Timolol Maleate Ophthalmic Solution 0.5%