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.
Drug: Loteprednol etabonate ophthalmic ointment
Drug: Vehicle Ophthalmic Ointment
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01749241
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01749241
United States (1)
Shiley Eye Center
La Jolla, California, United States, 92093
View full eligibility
Tris trial is registered with FDA with number: NCT01749241. The sponsor of the trial is University of California, San Diego and it is looking for 0 volunteers for the current phase.
Official trial title: Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
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