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Efficacy of Loteprednol Ointment Following Eyelid Surgery

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ClinicalTrials.gov Identifier: NCT01749241
Recruitment Status : Unknown
Verified December 2012 by Bobby Korn, MD, PhD, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : December 13, 2012
Last Update Posted : December 13, 2012
Sponsor:
Collaborators:
Shiley Eye Center
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bobby Korn, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Post-operative Healing Following Blepharoplasty and Ptosis Repair Drug: Loteprednol etabonate ophthalmic ointment Drug: Vehicle Ophthalmic Ointment Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Inflammation [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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