OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

August 28, 2019 updated by: Ocular Therapeutix, Inc.

A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 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)

68

Phase

  • Phase 2

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 ocular surgical intervention within the past 3 months
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the following disallowed medications during the period indicated

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
Time Frame: 14 days post insertion
Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
14 days post insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival Redness
Time Frame: 14 days post insertion
Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)
14 days post insertion

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

March 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-14-001

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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