A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 9/30/2018 |
| Start Date: | August 26, 2018 |
| End Date: | February 2019 |
| Contact: | William White |
| Email: | wsandywhite@gmail.com |
| Phone: | 205-306-8834 |
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
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.
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.
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
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