A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

Phase 1

Completed

• Conditions: Inflammation Eye
• Interventions: Drug: Dexamethasone

• Registration Number: NCT03687931
• Lead Sponsor: iDrop, Inc.

Brief Summary

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-26
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Exclusion Criteria

• Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
• Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
• Patients who are known steroid responders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Dexamethasone	Dexamethasone suspension dose level 1
Arm 2	Dexamethasone	Dexamethasone suspension dose level 2

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell	30 days	Number of cells in the anterior chamber

Trial Locations

Locations (1)

Arizona Eye Center; 🇺🇸 Chandler, Arizona, United States