Efficacy of Loteprednol Ointment Following Eyelid Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-operative Healing Following Blepharoplasty and Ptosis Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Loteprednol etabonate ointment

This is the arm which contains loteprednol steroid

Group Type EXPERIMENTAL

Loteprednol etabonate ophthalmic ointment

Intervention Type DRUG

Thin ribbon ointment to assigned eye twice daily for 14 days

Vehicle Ointment

This arm contains vehicle only.

Group Type OTHER

Vehicle Ophthalmic Ointment

Intervention Type DRUG

Thin ribbon ointment to assigned eye twice daily for 14 days

Interventions

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Loteprednol etabonate ophthalmic ointment

Thin ribbon ointment to assigned eye twice daily for 14 days

Intervention Type DRUG

Vehicle Ophthalmic Ointment

Thin ribbon ointment to assigned eye twice daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Lotemax ophthalmic ointment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes