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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539548
• Other study ID #: CLN-Protocol-0050
• Status: Completed
• Phase: Phase 3
• Start date: September 4, 2020
• Est. completion date: December 21, 2023

Study information

• Verified date: April 2024
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation

Intervention

Drug:
• Dextenza Ophthalmic Insert
0.4mg insert for intracanalicular use
• 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

Locations

Country	Name	City	State
United States	Ocular Therapeutix	Aurora	Colorado
United States	Ocular Therapeutix	Boston	Massachusetts
United States	Ocular Therapeutix	Charleston	South Carolina
United States	Ocular Therapeutix	Erie	Pennsylvania
United States	Ocular Therapeutix	Fort Collins	Colorado
United States	Ocular Therapeutix	Indianapolis	Indiana
United States	Ocular Therapeutix	Jacksonville	Florida
United States	Ocular Therapeutix	Lexington	Kentucky
United States	Ocular Therapeutix	Madison	Wisconsin
United States	Ocular Therapeutix	Minneapolis	Minnesota
United States	Ocular Therapeutix	Nashville	Tennessee
United States	Ocular Therapeutix	Rochester	Minnesota
United States	Ocular Therapeutix	Saint Louis	Missouri
United States	Ocular Therapeutix	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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