A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2025-01-24

Brief Summary

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To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

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Detailed Description

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This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel: Participants are assigned to one of three groups in parallel for the duration of the study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Sponsor, Study Coordinator, Investigator

Study Groups

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OTX-TIC Low Dose

Travoprost Intracameral Implant low dose

Group Type EXPERIMENTAL

OTX-TIC low dose Travoprost Intracameral Implant

Intervention Type DRUG

OTX-TIC implant is injected into the anterior chamber of the eye.

OTX-TIC High Dose

Travoprost Intracameral Implant high dose

Group Type EXPERIMENTAL

OTX-TIC high dose Travoprost Intracameral Implant

Intervention Type DRUG

OTX-TIC implant is injected into the anterior chamber of the eye.

Durysta

Bimatoprost Intracameral Implant 10 µg

Group Type ACTIVE_COMPARATOR

Durysta, Bimatoprost Intracameral Implant 10 µg

Intervention Type DRUG

Durysta is injected into the anterior chamber of the eye.

Interventions

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OTX-TIC low dose Travoprost Intracameral Implant

OTX-TIC implant is injected into the anterior chamber of the eye.

Intervention Type DRUG

OTX-TIC high dose Travoprost Intracameral Implant

OTX-TIC implant is injected into the anterior chamber of the eye.

Intervention Type DRUG

Durysta, Bimatoprost Intracameral Implant 10 µg

Durysta is injected into the anterior chamber of the eye.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Are 18 years of age or older at the time of screening
* Provide written informed consent and are able to comply with all study requirements
* Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
* Have a negative pregnancy test result for women of childbearing potential at Baseline
* Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria

* Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
* Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
* Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No