Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Ocular Therapeutix

Status and phase: Completed; Phase 2

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol; Drug: OTX-TP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02312544

OTX-13-004

Details and patient eligibility

About

To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension. The study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component).

• Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of

  ≥ 24mmHg at Hour 0 (T0) at Baseline Visit 1 and Baseline Visit 2 (Day 1)

• Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of:

  ≥ 22mmHg at (T0 + 4h) and (T0 + 8h) at Baseline Visit 1 (note: the same eye must meet the IOP eligibility criteria at all 4 baseline assessments)

• Washout IOP must be ≤ 34mmHg in each eye at all time points at the Baseline Visit 1 and Baseline Visit 2 (Day 1)

Exclusion criteria

• Subject with any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
• Subject with mean baseline IOP >34 mmHg in either eye at any time point during the Baseline Visits 1 or 2 (Day 1).
• Subject with a BCVA worse than 0.6 logMAR (20/80 Snellen) in either eye as measured using an ETDRS chart.
• Subject with a known or suspected allergy and/or hypersensitivity to travoprost, timolol, fluorescein or to any component of the study products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

OTX-TP treatment

Active Comparator group

Description:

OTX-TP (sustained release travoprost, 0.36 mg) to be used in this trial with placebo drops administered separately

Treatment:

Drug: OTX-TP

Timolol control

Active Comparator group

Description:

Timolol Maleate Ophthalmic Solution, 0.5% dosed twice daily (BID) in the presence of a placebo vehicle punctum plug (PV).

Treatment:

Drug: Timolol