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

Ocular Therapeutix

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Dextenza Ophthalmic Insert; Drug: Prednisolone acetate ophthalmic suspension USP 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04539548

CLN-Protocol-0050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Dextenza

Experimental group

Description:

1 dosing group - 37 eyes treated with Dextenza

Treatment:

Drug: Dextenza Ophthalmic Insert

Prednisolone

Active Comparator group

Description:

1 dosing group - 32 eyes treated with Prednisolone

Treatment:

Drug: Prednisolone acetate ophthalmic suspension USP 1%