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

NCT05550363 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: EYP-DIP-302
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

  Day 8

Secondary Outcomes (7)

• 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

• Mean ocular pain scores in the study eye

  Days 1, 3, 15, and 30

• Proportion of subjects with absence of cells in the AC of the study eye

  Days 1, 3, 15, and 30

• Proportion of subjects with absence of flare in the AC of the study eye

  Days 1, 3, 15, and 30

• Mean AC cell score in the study eye

  Days 1, 3, 15, and 30

Study Arms (2)

DEXYCU

EXPERIMENTAL

DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg

Drug: Dexycu

Placebo

PLACEBO COMPARATOR

Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

Other: Placebo/Vehicle

Interventions

Dexycu DRUG

103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg

DEXYCU

Placebo/Vehicle OTHER

Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 22, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 3, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share