Overview

Efficacy of Loteprednol Ointment Following Eyelid Surgery

Status:
Withdrawn
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
Summary
Inflammation occurs after any type of incisional surgery. This study will evaluate the efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative inflammation after routine eyelid surgery.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
Bausch & Lomb Incorporated
Shiley Eye Center
Treatments:
Loteprednol Etabonate
Criteria
Inclusion Criteria:

- Age > 18 years old

- Scheduled for bilateral eyelid surgery

- Willing and able to return for all study visits

- Willing and able to administer treatments as required

- Understand and sign informed consent approved by UCSD institutional review board

Exclusion Criteria:

- History of allergy to investigational drug (Loteprednol etabonate) or ingredient in
drug including petrolatum

- History of collagen vascular disease and receiving concurrent treatment that could
interfere with interpretation of study results

- Concurrent ocular therapy with nonsteroidal anti-inflammatory drugs, mast cell
stabilizers, antihistamines, decongestants, immunosuppresants, and systemic or ocular
corticosteroids

- History of immunodeficiency

- Prior eyelid or facial surgery

- Prior ocular or orbital trauma

- History of ocular hypertension, steroid responder, or glaucoma

- Pregnancy or lactation

- Uncontrolled systemic disease or significant illness

- Any other condition the investigator believe would pose a significant hazard to the
subject if the investigational therapy were initiated