- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445326
OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
March 2, 2018 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)
73
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)
- 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
|
|
Placebo Comparator: PV
PV (placebo drug delivery 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=None
|
3 minutes
|
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time Frame: 5 minutes
|
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
|
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=None
|
7 minutes
|
Conjunctival Redness 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=None
|
7 minutes
|
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time Frame: 15 minutes
|
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
|
15 minutes
|
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time Frame: 20 minutes
|
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
April 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
May 13, 2015
First Submitted That Met QC Criteria
May 14, 2015
First Posted (Estimate)
May 15, 2015
Study Record Updates
Last Update Posted (Actual)
March 29, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- OTX-14-007
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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