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

EyePoint Pharmaceuticals

Status and phase: Withdrawn; Phase 3

Conditions: Cataract

Treatments: Drug: Dexycu; Other: Placebo/Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05550350

EYP-DIP-301

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups, including a placebo group

DEXYCU

Experimental group

Description:

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

Treatment:

Drug: Dexycu

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo/Vehicle