CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2021-05-24

Brief Summary

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To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

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Detailed Description

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This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

Conditions

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Ocular Hypertension Open Angle Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OTX-TIC-Cohort 1

15 µg (formulation1) implant

Group Type EXPERIMENTAL