OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

September 14, 2020 updated by: Ocular Therapeutix, Inc.

A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
  • Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

  • History of refractive surgery (including LASIK procedures) within the past 2 years
  • History of retinal detachment, diabetic retinopathy, or active retinal disease
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the disallowed medications during the period indicated
  • History of IOP increase as a result of steroid treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Drug: Dexamethasone
Placebo Comparator: PV
PV (placebo drug delivery vehicle)
Other: Placebo Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time Frame: 3 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
3 minutes
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
Time Frame: 5 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
5 minutes
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time Frame: 7 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
7 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Collaborators

ORA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

April 27, 2016

Study Completion (Actual)

April 27, 2016

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-15-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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