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

Sponsor

Ocular Therapeutix, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04539548

Collaborator

(none)

Enrollment

Locations

Arms

25.8

Anticipated Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dextenza Drug: Prednisolone	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 4, 2020

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dextenza 1 dosing group - Approximately 30 subjects treated with Dextenza	Drug: Dextenza Dextenza, dexamethasone ophthalmic insert
Active Comparator: Prednisolone 1 dosing group - Approximately 30 subjects treated with Prednisolone	Drug: Prednisolone Prednisolone, acetate ophthalmic suspension

Arm

Intervention/Treatment

Experimental: Dextenza

1 dosing group - Approximately 30 subjects treated with Dextenza

Drug: Dextenza

Dextenza, dexamethasone ophthalmic insert

Active Comparator: Prednisolone

1 dosing group - Approximately 30 subjects treated with Prednisolone

Drug: Prednisolone

Prednisolone, acetate ophthalmic suspension

Outcome Measures

Primary Outcome Measures

Absence of pain [8 days post treatment]
FLACC score of '0' (Face, Legs, Activity, Cry, Consolability)

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 3 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocular Therapeutix	Aurora	Colorado	United States	80045
2	Ocular Therapeutix	Fort Collins	Colorado	United States	80525
3	Ocular Therapeutix	Jacksonville	Florida	United States	32202
4	Ocular Therapeutix	Indianapolis	Indiana	United States	46202
5	Ocular Therapeutix	Lexington	Kentucky	United States	40508
6	Ocular Therapeutix	Boston	Massachusetts	United States	02115
7	Ocular Therapeutix	Minneapolis	Minnesota	United States	55454
8	Ocular Therapeutix	Rochester	Minnesota	United States	55905
9	Ocular Therapeutix	Saint Louis	Missouri	United States	63110
10	Ocular Therapeutix	Erie	Pennsylvania	United States	16501
11	Ocular Therapeutix	Charleston	South Carolina	United States	29425
12	Ocular Therapeutix	Nashville	Tennessee	United States	37232
13	Ocular Therapeutix	Virginia Beach	Virginia	United States	23452
14	Ocular Therapeutix	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ocular Therapeutix, Inc.

ClinicalTrials.gov Identifier:

NCT04539548

Other Study ID Numbers:

CLN-Protocol-0050

First Posted:

Sep 7, 2020

Last Update Posted:

Jan 28, 2022

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ocular Therapeutix, Inc.

Dextenza, dexamethasone ophthalmic insert

Additional relevant MeSH terms:

Cataract

Inflammation

Prednisolone

Study Results

No Results Posted as of Jan 28, 2022