Trial | NCT03687931  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
Study Started
Aug 26
2018
Primary Completion
Feb 28
2019
Study Completion
Feb 28
2019
Last Update
May 24
2019

Drug Dexamethasone

Drop

Arm 1 Experimental

Dexamethasone suspension dose level 1

Arm 2 Experimental

Dexamethasone suspension dose level 2

Criteria 

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
No Results Posted