Clinical trial NCT01749241: Efficacy of Loteprednol Ointment Following Eyelid Surgery
Official title: Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-operative Healing Following Blepharoplasty and Ptosis Repair
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Shiley Eye Center
name: Bausch & Lomb Incorporated
First posted: 2012-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inflammation
timeFrame: 24 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley Eye Center
state: California
Study officials:
affiliation: UCSD Med
name: Bobby Korn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Comstock TL, Paterno MR, Singh A, Erb T, Davis E. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol. 2011;5:177-86. doi: 10.2147/OPTH.S16832. Epub 2011 Feb 10.
citation: A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. The Loteprednol Etabonate Postoperative Inflammation Study Group 2. Ophthalmology. 1998 Sep;105(9):1780-6. doi: 10.1016/s0161-6420(98)99054-6.