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

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Prednisolone acetate ophthalmic suspension USP 1%; Drug: Dextenza Ophthalmic Insert

• Registration Number: NCT04539548
• Lead Sponsor: Ocular Therapeutix, Inc.

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.

Study Timeline

• Study First Submitted: 2020-08-27
• Study Start: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone	Prednisolone acetate ophthalmic suspension USP 1%	1 dosing group - 32 eyes treated with Prednisolone
Dextenza	Dextenza Ophthalmic Insert	1 dosing group - 37 eyes treated with Dextenza

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ocular Therapeutix; 🇺🇸 Madison, Wisconsin, United States