Efficacy of Loteprednol Ointment Following Eyelid Surgery

University of California San Diego

Status

Withdrawn

Conditions

Post-operative Healing Following Blepharoplasty and Ptosis Repair

Treatments

Drug: Loteprednol etabonate ophthalmic ointment

Drug: Vehicle Ophthalmic Ointment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01749241

BL31929

Details and patient eligibility

About

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.

Full description

Eyelid surgery such as blepharoplasty is often performed for functional and cosmetic indications. Following any incisional surgery, postoperative inflammation occurs at the surgical site. This study will evaluate the efficacy of reducing postoperative inflammation after bilateral eyelid surgery using Loteprednol etabonate (steroid) vs. Soothe ointment (vehicle of Loteprednol etabonate). Common postoperative changes at the incision include: erythema, thickening/elevation of the skin, pigmentary changes and pain. The use of a topically applied steroid would be expected to reduce inflammation and this study will evaluate this. For each patient, one eyelid will be randomly chosen to treat with medication and the other eyelid will be treated with vehicle ointment and by using the same patient, each patient will be internally controlled. Antibiotic prophylaxis is often given after eyelid surgery and this will be used in all patients in the study.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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