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Efficacy of Loteprednol Ointment Following Eyelid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01749241
Recruitment Status : Withdrawn (no participant enrolled)
First Posted : December 13, 2012
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Shiley Eye Center
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bobby Korn, MD, PhD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE December 10, 2012
First Posted Date  ICMJE December 13, 2012
Last Update Posted Date August 2, 2019
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Loteprednol Ointment Following Eyelid Surgery
Official Title  ICMJE Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Healing Following Blepharoplasty and Ptosis Repair
Intervention  ICMJE
  • Drug: Loteprednol etabonate ophthalmic ointment
    Thin ribbon ointment to assigned eye twice daily for 14 days
    Other Name: Lotemax ophthalmic ointment
  • Drug: Vehicle Ophthalmic Ointment
    Thin ribbon ointment to assigned eye twice daily for 14 days
Study Arms  ICMJE
  • Experimental: Loteprednol etabonate ointment
    This is the arm which contains loteprednol steroid
    Intervention: Drug: Loteprednol etabonate ophthalmic ointment
  • Vehicle Ointment
    This arm contains vehicle only.
    Intervention: Drug: Vehicle Ophthalmic Ointment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)
100
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01749241
Other Study ID Numbers  ICMJE BL31929
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bobby Korn, MD, PhD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE
  • Shiley Eye Center
  • Bausch & Lomb Incorporated
Investigators  ICMJE
Principal Investigator: Bobby Korn, MD PhD UCSD Med
PRS Account University of California, San Diego
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP