Back to resultsPhase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Primary Purpose
Ocular Inflammation and Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTX-DP (Dexamethasone punctum plug)
Placebo Vehicle Punctum Plug
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Inflammation and Pain
Eligibility Criteria
Inclusion Criteria:
- Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
- Is greater than or equal to 21 years of age
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
Exclusion Criteria:
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
- Score greater than "0" on the Ocular Pain Assessment at Screening
- Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
Sites / Locations
- Chicago Cornea Consultants, Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexamethasone Punctum Plug
Placebo Vehicle Punctum Plug
Arm Description
Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
Placebo punctum plug insertion
Outcomes
Primary Outcome Measures
Absence of Cells in Anterior Chamber of Study Eye
Absence of Pain in the Study Eye
Secondary Outcome Measures
Full Information
NCT ID
NCT01666210
First Posted
August 14, 2012
Last Updated
September 23, 2021
Sponsor
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01666210
Brief Title
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Official Title
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation and Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Punctum Plug
Arm Type
Active Comparator
Arm Description
Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
Arm Title
Placebo Vehicle Punctum Plug
Arm Type
Placebo Comparator
Arm Description
Placebo punctum plug insertion
Intervention Type
Drug
Intervention Name(s)
OTX-DP (Dexamethasone punctum plug)
Intervention Description
Sustained and tapered release of dexamethasone from hydrogel punctum plug
Intervention Type
Drug
Intervention Name(s)
Placebo Vehicle Punctum Plug
Intervention Description
Hydrogel punctum plug without dexamethasone
Primary Outcome Measure Information:
Title
Absence of Cells in Anterior Chamber of Study Eye
Time Frame
Day 8
Title
Absence of Pain in the Study Eye
Time Frame
Day 8
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Measure of adverse events over the duration of each subject's participation in the study.
Time Frame
Duration of each individual subject's participation in the study, up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
Is greater than or equal to 21 years of age
Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
Exclusion Criteria:
Any intraocular inflammation in the study eye present during the screening slit lamp examination
Score greater than "0" on the Ocular Pain Assessment at Screening
Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
Facility Information:
Facility Name
Chicago Cornea Consultants, Ltd.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
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