Overview

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

Status:
Completed
Trial end date:
2019-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
iDrop, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
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