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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05550363
• Other study ID #: EYP-DIP-302
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2022
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Dexycu
103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg

Other:
• Placebo/Vehicle
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8		Day 8
Secondary	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
Secondary	Mean ocular pain scores in the study eye	Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe	Days 1, 3, 15, and 30
Secondary	Proportion of subjects with absence of cells in the AC of the study eye		Days 1, 3, 15, and 30
Secondary	Proportion of subjects with absence of flare in the AC of the study eye		Days 1, 3, 15, and 30
Secondary	Mean AC cell score in the study eye	AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe	Days 1, 3, 15, and 30
Secondary	Mean AC flare score in the study eye	AC flare by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity	Days 1, 3, 15, and 30
Secondary	Rates of ocular (study eye and fellow eye) and non-ocular TEAEs		up to day 30