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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

Primary Purpose

Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OTX-TP

Timolol

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Vold Vision

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

OTX-TP treatment

Timolol control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit

Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit

Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits

Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits

Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits

Secondary Outcome Measures

Full Information

NCT ID

NCT02312544

First Posted

December 4, 2014

Last Updated

December 13, 2016

Sponsor

Ocular Therapeutix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02312544

Brief Title

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

Official Title

A Prospective, Multicenter, Randomized, Double-Masked, Parallel-Arm Phase 2b Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ocular Therapeutix, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OTX-TP treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Timolol control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

OTX-TP

Intervention Description

OTX-TP and placebo drops

Intervention Type

Drug

Intervention Name(s)

Timolol

Intervention Description

Timolol drops and placebo punctum plug

Primary Outcome Measure Information:

Title

Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit

Time Frame

Days 57 to 63

Title

Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit

Time Frame

Days 87 to 93

Title

Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits

Time Frame

Days 57 to 63 and Days 87 to 93

Title

Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits

Time Frame

Days 57 to 63 and Days 87 to 93

Title

Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits

Time Frame

Days 57 to 63 and 87 to 93

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Vold Vision

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72704

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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