Efficacy of Loteprednol Ointment Following Eyelid Surgery

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery

Conditions
-----------------
Post-operative Healing Following Blepharoplasty and Ptosis Repair

Intervention / Treatment
-----------------
* Drug: Loteprednol etabonate ophthalmic ointment
* Drug: Vehicle Ophthalmic Ointment


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol etabonate ointment<br>This is the arm which contains loteprednol steroid | Drug: Loteprednol etabonate ophthalmic ointment<br>* Thin ribbon ointment to assigned eye twice daily for 14 days<br>* Other names: Lotemax ophthalmic ointment;|
| Other: Vehicle Ointment<br>This arm contains vehicle only. | Drug: Vehicle Ophthalmic Ointment<br>* Thin ribbon ointment to assigned eye twice daily for 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Inflammatory changes of the periocular skin will be assessed by several criteria including: 1. Erythema 2. Wound elevation 3. Pigmentary changes 4. Exudate 5. Excoriation 6. Crusting 7. Scaling 8. Pain 9. Itching | 24 weeks after surgery |