Post-operative Healing Following Blepharoplasty and Ptosis Repair
Conditions
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.
Interventions
DRUGLoteprednol etabonate ophthalmic ointment
Thin ribbon ointment to assigned eye twice daily for 14 days
DRUGVehicle Ophthalmic Ointment
Thin ribbon ointment to assigned eye twice daily for 14 days
Sponsors
Shiley Eye Center
Bausch & Lomb Incorporated
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed