- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01749241
Efficacy of Loteprednol Ointment Following Eyelid Surgery
July 31, 2019 updated by: Bobby Korn, MD, PhD, University of California, San Diego
Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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La Jolla, California, United States, 92093
- Shiley Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Loteprednol etabonate ointment
This is the arm which contains loteprednol steroid
|
Thin ribbon ointment to assigned eye twice daily for 14 days
Other Names:
|
Other: Vehicle Ointment
This arm contains vehicle only.
|
Thin ribbon ointment to assigned eye twice daily for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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24 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bobby Korn, MD PhD, UCSD Med
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 2011 Feb 10.
- 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. doi: 10.1016/s0161-6420(98)99054-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 10, 2012
First Submitted That Met QC Criteria
December 11, 2012
First Posted (Estimate)
December 13, 2012
Study Record Updates
Last Update Posted (Actual)
August 2, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BL31929
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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