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

NCT02312544 | Completed Phase 2

• 1 other identifier: OTX-13-004
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (5)

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

  Days 57 to 63

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

  Days 87 to 93

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

  Days 57 to 63 and Days 87 to 93

• 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

  Days 57 to 63 and Days 87 to 93

• 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

  Days 57 to 63 and 87 to 93

Study Arms (2)

OTX-TP treatment

ACTIVE COMPARATOR

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

Drug: OTX-TP

Timolol control

ACTIVE COMPARATOR

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

Drug: Timolol

Interventions

OTX-TP DRUG

OTX-TP and placebo drops

OTX-TP treatment

Timolol DRUG

Timolol drops and placebo punctum plug

Timolol control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (1)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 9, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

US (1)