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Efficacy of Loteprednol Ointment Following Eyelid Surgery

This study is currently recruiting participants.
Verified December 2012 by University of California, San Diego
Sponsor:
Collaborators:
Shiley Eye Center
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bobby Korn, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01749241
First received: December 10, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Post-operative Healing Following Blepharoplasty and Ptosis Repair
 Drug: Loteprednol etabonate ophthalmic ointment
Drug: Vehicle Ophthalmic Ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Inflammation [ Time Frame: 24 weeks after surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol etabonate ointment
This is the arm which contains loteprednol steroid
 Drug: Loteprednol etabonate ophthalmic ointment
Thin ribbon ointment to assigned eye twice daily for 14 days
Other Name: Lotemax ophthalmic ointment
Vehicle Ointment
This arm contains vehicle only.
 Drug: Vehicle Ophthalmic Ointment
Thin ribbon ointment to assigned eye twice daily for 14 days

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749241

Contacts
Contact: Annaleah Ariola 858-534-7402 aariola@ucsd.edu
Contact: Bobby Korn, MD PhD 858-534-7402 bkorn@ucsd.edu

Locations
United States, California
Shiley Eye Center Recruiting
La Jolla, California, United States, 92093
Contact: Catherine Ledford, MBA     858-534-2109     cledford@ucsd.edu    
Contact: Caitlin Chu     858-534-6866     cvchu@ucsd.edu    
Principal Investigator: Bobby Korn, MD, PhD            
Sub-Investigator: Don Kikkawa, MD            
Sponsors and Collaborators
University of California, San Diego
Shiley Eye Center
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Bobby Korn, MD PhD UCSD Med
  More Information

Publications:

Responsible Party: Bobby Korn, MD, PhD, Associate Professor of Ophthalmology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01749241     History of Changes
Other Study ID Numbers: BL31929
Study First Received: December 10, 2012
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013