A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)

• Sponsor: EyePoint Pharmaceuticals, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05550363
• Collaborator: (none)
• Enrollment: 150
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dexycu; Other: Placebo/Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter StudyProspective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DEXYCU DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg	Drug: Dexycu; 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Placebo Comparator: Placebo Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg	Other: Placebo/Vehicle; Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8 [Day 8]

Secondary Outcome Measures

1. Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30 [Days 1, 3, 15, and 30]

2. Mean ocular pain scores in the study eye [Days 1, 3, 15, and 30]

   Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe

3. Proportion of subjects with absence of cells in the AC of the study eye [Days 1, 3, 15, and 30]

4. Proportion of subjects with absence of flare in the AC of the study eye [Days 1, 3, 15, and 30]

5. Mean AC cell score in the study eye [Days 1, 3, 15, and 30]

   AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe

6. Mean AC flare score in the study eye [Days 1, 3, 15, and 30]

   AC flare by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity

7. Rates of ocular (study eye and fellow eye) and non-ocular TEAEs [up to day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects at least 40 years of age scheduled for cataract surgery

• Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye

• Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.

Exclusion Criteria:

• Use of any corticosteroids within 7 days prior to Day 0

• Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days

• Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• EyePoint Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EyePoint Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05550363
• Other Study ID Numbers: EYP-DIP-302
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 23, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Sep 23, 2022