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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2023-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dextenza

1 dosing group - 37 eyes treated with Dextenza

Group Type EXPERIMENTAL

Dextenza Ophthalmic Insert

Intervention Type DRUG

0.4mg insert for intracanalicular use

Prednisolone

1 dosing group - 32 eyes treated with Prednisolone

Group Type ACTIVE_COMPARATOR

Prednisolone acetate ophthalmic suspension USP 1%

Intervention Type DRUG

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

Interventions

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Dextenza Ophthalmic Insert

0.4mg insert for intracanalicular use

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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DEXTENZA

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No