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®

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Loteprednol etabonate
* Drug: Artificial Tears
* Drug: Restasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loteprednol etabonate + Restasis<br>Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days | Drug: Loteprednol etabonate<br> <br> Drug: Restasis<br> <br> |
| Placebo Comparator: Artificial Tears + Restasis<br>Artificial Tears, BID 30 days Restasis, BID 45 days | Drug: Artificial Tears<br> <br> Drug: Restasis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein corneal staining scores |  | 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lissamine green conjunctival staining |  | 60 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye