Back to resultsOTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Primary Purpose
Chronic Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OTX-DP
PV
Arm Description
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
PV (placebo drug delivery vehicle)
Outcomes
Primary Outcome Measures
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Secondary Outcome Measures
Full Information
NCT ID
NCT02988882
First Posted
December 2, 2016
Last Updated
September 14, 2020
Sponsor
Ocular Therapeutix, Inc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02988882
Brief Title
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Official Title
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®)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 27, 2016 (Actual)
Study Completion Date
April 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
Collaborators
ORA, Inc.
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTX-DP
Arm Type
Experimental
Arm Description
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Arm Title
PV
Arm Type
Placebo Comparator
Arm Description
PV (placebo drug delivery vehicle)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Other
Intervention Name(s)
Placebo Vehicle
Primary Outcome Measure Information:
Title
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Description
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Time Frame
3 minutes
Title
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
Description
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Time Frame
5 minutes
Title
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Description
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Time Frame
7 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
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