Efficacy of Loteprednol Ointment Following Eyelid Surgery

Not Applicable

Withdrawn

• Conditions: Post-operative Healing Following Blepharoplasty and Ptosis Repair
• Interventions: Drug: Loteprednol etabonate ophthalmic ointment; Drug: Vehicle Ophthalmic Ointment

• Registration Number: NCT01749241
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol etabonate ointment	Loteprednol etabonate ophthalmic ointment	This is the arm which contains loteprednol steroid
Vehicle Ointment	Vehicle Ophthalmic Ointment	This arm contains vehicle only.

Primary Outcome Measures

Name	Time	Method
Inflammation	24 weeks after surgery	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

Trial Locations

Locations (1)

Shiley Eye Center; 🇺🇸 La Jolla, California, United States