Efficacy of Loteprednol Ointment Following Eyelid Surgery

Post-operative Healing Following Blepharoplasty and Ptosis Repair Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01749241
• Other study ID #: BL31929
• Status: Withdrawn
• Phase: N/A
• Start date: September 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-operative Healing Following Blepharoplasty and Ptosis Repair

Intervention

Drug:
• Loteprednol etabonate ophthalmic ointment
Thin ribbon ointment to assigned eye twice daily for 14 days
• Vehicle Ophthalmic Ointment
Thin ribbon ointment to assigned eye twice daily for 14 days

Locations

Country	Name	City	State
United States	Shiley Eye Center	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Bausch & Lomb Incorporated, Shiley Eye Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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