NCT04539548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2020

Typical duration for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

August 27, 2020

Last Update Submit

April 11, 2024

Conditions

Cataract

Keywords

Dextenza, dexamethasone ophthalmic insert

Outcome Measures

Primary Outcomes (3)

  • 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

  • Subject FLACC Pain Assessment

    Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).

    From screening through day 42

  • IOP

    IOP measured in units of mmHg.

    From screening, then day 2 through 42

Study Arms (2)

Dextenza

EXPERIMENTAL

1 dosing group - 37 eyes treated with Dextenza

Drug: Dextenza Ophthalmic Insert

Prednisolone

ACTIVE COMPARATOR

1 dosing group - 32 eyes treated with Prednisolone

Drug: Prednisolone acetate ophthalmic suspension USP 1%

Interventions

Dextenza Ophthalmic InsertDRUG

0.4mg insert for intracanalicular use

Also known as: DEXTENZA
Dextenza
Prednisolone acetate ophthalmic suspension USP 1%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

Prednisolone

Eligibility Criteria

Age0 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ocular Therapeutix

Aurora, Colorado, 80045, United States

Location

Ocular Therapeutix

Fort Collins, Colorado, 80525, United States

Location

Ocular Therapeutix

Jacksonville, Florida, 32202, United States

Location

Ocular Therapeutix

Indianapolis, Indiana, 46202, United States

Location

Ocular Therapeutix

Lexington, Kentucky, 40508, United States

Location

Ocular Therapeutix

Boston, Massachusetts, 02115, United States

Location

Ocular Therapeutix

Minneapolis, Minnesota, 55454, United States

Location

Ocular Therapeutix

Rochester, Minnesota, 55905, United States

Location

Ocular Therapeutix

St Louis, Missouri, 63110, United States

Location

Ocular Therapeutix

Erie, Pennsylvania, 16501, United States

Location

Ocular Therapeutix

Charleston, South Carolina, 29425, United States

Location

Ocular Therapeutix

Nashville, Tennessee, 37232, United States

Location

Ocular Therapeutix

Virginia Beach, Virginia, 23452, United States

Location

Ocular Therapeutix

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 7, 2020

Study Start

September 4, 2020

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations

US(14)