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A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Primary Purpose

Cataract

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dextenza
Prednisolone
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Dextenza, dexamethasone ophthalmic insert

Eligibility Criteria

0 Years - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric cataract diagnosis
  • Subject is >0 - 3 years of age

Exclusion Criteria:

  • Any intraocular inflammation in the study eye
  • Ocular hypertension or glaucoma
  • Evidence of acute external ocular infections

Sites / Locations

  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting
  • Ocular TherapeutixRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dextenza

Prednisolone

Arm Description

1 dosing group - Approximately 30 subjects treated with Dextenza

1 dosing group - Approximately 30 subjects treated with Prednisolone

Outcomes

Primary Outcome Measures

Absence of pain
FLACC score of '0' (Face, Legs, Activity, Cry, Consolability)

Secondary Outcome Measures

Full Information

First Posted
August 27, 2020
Last Updated
January 27, 2022
Sponsor
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04539548
Brief Title
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Official Title
A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

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
Yes

5. Study Description

Brief Summary
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Detailed Description
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Dextenza, dexamethasone ophthalmic insert

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dextenza
Arm Type
Experimental
Arm Description
1 dosing group - Approximately 30 subjects treated with Dextenza
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
1 dosing group - Approximately 30 subjects treated with Prednisolone
Intervention Type
Drug
Intervention Name(s)
Dextenza
Intervention Description
Dextenza, dexamethasone ophthalmic insert
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone, acetate ophthalmic suspension
Primary Outcome Measure Information:
Title
Absence of pain
Description
FLACC score of '0' (Face, Legs, Activity, Cry, Consolability)
Time Frame
8 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric cataract diagnosis Subject is >0 - 3 years of age Exclusion Criteria: Any intraocular inflammation in the study eye Ocular hypertension or glaucoma Evidence of acute external ocular infections
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Project Manager
Phone
781-357-4000
Email
clinicalaffairs@ocutx.com
Facility Information:
Facility Name
Ocular Therapeutix
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager

12. IPD Sharing Statement

Learn more about this trial

A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

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