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

April 11, 2024 updated by: Ocular Therapeutix, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Ocular Therapeutix
      • Fort Collins, Colorado, United States, 80525
        • Ocular Therapeutix
    • Florida
      • Jacksonville, Florida, United States, 32202
        • Ocular Therapeutix
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Ocular Therapeutix
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Ocular Therapeutix
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Ocular Therapeutix
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Ocular Therapeutix
      • Rochester, Minnesota, United States, 55905
        • Ocular Therapeutix
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Ocular Therapeutix
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16501
        • Ocular Therapeutix
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Ocular Therapeutix
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Ocular Therapeutix
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • Ocular Therapeutix
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Ocular Therapeutix

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

1 second to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is >5 years of age)
  • Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens

Exclusion Criteria:

  • Any intraocular inflammation in the study eye present during the screening slit lamp examination
  • Has ocular hypertension (defined as IOP of >21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases
  • Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextenza
1 dosing group - 37 eyes treated with Dextenza
Drug: Dextenza Ophthalmic Insert
0.4mg insert for intracanalicular use
Other Names:
  • DEXTENZA
Active Comparator: Prednisolone
1 dosing group - 32 eyes treated with Prednisolone
Drug: Prednisolone acetate ophthalmic suspension USP 1%

1 drop at end of surgery, followed by:

1 drop 4 x QID for one week.

1 drop 3 x QID for one week.

1 drop BID for one week.

1 drop QD for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to approximately 42 days after surgery
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Up to approximately 42 days after surgery
Subject FLACC Pain Assessment
Time Frame: From screening through day 42
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
From screening through day 42
IOP
Time Frame: From screening, then day 2 through 42
IOP measured in units of mmHg.
From screening, then day 2 through 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

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)

September 4, 2020

Primary Completion (Actual)

December 21, 2023

Study Completion (Actual)

December 21, 2023

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-Protocol-0050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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