A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®

Withdrawn before enrolling · Phase 4

Conditions studied: Dry Eye Disease

In brief

A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.

Key facts

Study ID

NCT02028312

Run by

Edward Holland, MD

People needed

0

Starts

2014-01-01

Expected to finish

2016-06-01

Last updated by the study team

2015-03-18

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Are between the ages of 21 and 80 inclusive.
• Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.
• Have been on stable oral medications for 1 month prior to the study.
• Are in generally good and stable overall health.
• Are a woman of child bearing potential (WOCBP) who is not pregnant or lactating and not sexually active (i.e. abstinent) at Visit 1 and willing to remain so through Visit 4. Alternatively, a WOCBP who is not abstinent must have been using an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study.
• Are women who have undergone one of the following sterilization procedures at least 1 month prior to Visit 1:
• Bilateral tubal ligation
• Hysterectomy
• Hysterectomy with unilateral or bilateral oophorectomy.
• Bilateral oophorectomy
• Are likely to comply with the eye drop regime, study guidelines, and study visits.

You may not qualify if…

• Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
• Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
• Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
• Have a history of liver disease.
• Be pregnant or lactating.
• Have severe clinical vitamin deficiencies or a history of vitamin overdose.
• Have a highly variable vitamin intake.
• Wear contact lenses.
• Have unstable use of systemic or topical medications known to create dry eye.
• Have corneal pathology, which could, of itself, cause an ocular surface disorder.
• Have used glaucoma medications, topical or oral within 30 days of Visit 1/Screening and Baseline Visit.
• Have unstable diabetes mellitus.
• Have an allergy or sensitivity to Lotemax® Gel, Restasis®, or non-preservative artificial tears.
• Have used topical steroids or Restasis® within 1 month prior to the Screening and Baseline Visit and throughout the study, except the study medication provided per the protocol.
• Have a condition for which steroid use would be contraindicated (e.g. viral infection).
• Use other topical ocular agents other than tear replacements within 1 week prior to the Screening and Baseline Visit and throughout the study.
• Have been exposed to an investigational drug within the preceding 30 days.
• In the opinion of the investigator or study coordinator, be unwilling or unable to comply with the study protocol or unable to successfully instill eye drops.

Where it is running

• Cincinnati Eye Institute — Edgewood, Kentucky, United States

Full record on ClinicalTrials.gov

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