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

Inflammation Eye Clinical Trial

Official title:

A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687931
• Other study ID #: C-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 26, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2019
• Source: iDrop, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Inflammation Eye

Intervention

Drug:
• Dexamethasone
Drop

Locations

Country	Name	City	State
United States	Arizona Eye Center	Chandler	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
iDrop, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior Chamber Cell	Number of cells in the anterior chamber	30 days