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Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Primary Purpose

Post Ocular Surgical Inflammation and Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Punctum Plug
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Ocular Surgical Inflammation and Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
  • Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

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 in the study eye at Screening
  • Any intraocular inflammation in the study eye present during the screening slit lamp examination

Sites / Locations

  • Texan Eye / Keystone Research, Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OTX-DP (Dexamethasone Punctum Plug)

PVPP (Placebo Punctum Plug)

Arm Description

Resorbable hydrogel drug delivery vehicle containing dexamethasone

Resorbable hydrogel drug delivery vehicle containing no drug

Outcomes

Primary Outcome Measures

Absence of Cells in Anterior Chamber of the Study Eye
Absence of Pain in Study Eye

Secondary Outcome Measures

Full Information

First Posted
January 9, 2014
Last Updated
January 22, 2020
Sponsor
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02034019
Brief Title
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
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 post-surgical 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
Post Ocular Surgical Inflammation and Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTX-DP (Dexamethasone Punctum Plug)
Arm Type
Active Comparator
Arm Description
Resorbable hydrogel drug delivery vehicle containing dexamethasone
Arm Title
PVPP (Placebo Punctum Plug)
Arm Type
Placebo Comparator
Arm Description
Resorbable hydrogel drug delivery vehicle containing no drug
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Punctum Plug
Primary Outcome Measure Information:
Title
Absence of Cells in Anterior Chamber of the Study Eye
Time Frame
Day 14
Title
Absence of Pain in Study Eye
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes 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 in the study eye at Screening Any intraocular inflammation in the study eye present during the screening slit lamp examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Organizational Affiliation
Ocular Therapeutix
Official's Role
Study Director
Facility Information:
Facility Name
Texan Eye / Keystone Research, Ltd.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

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