A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.

Official Title
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A Dose-Finding Study To Compare The Safety, Tolerability, And Efficacy Of Differing Dosing Regimens Of ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution) To Vehicle And DuraSite Alone In Dry Eye Disease Volunteers

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: ISV 101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease. Negative pregnancy test prior to the conduct of any protocol-specific procedure. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months Signature of the subject on the Informed Consent Form Willing to avoid disallowed medication for the duration of the study. Able to self-administer study drug (or have a caregiver available to instill all doses of study drug) Able and willing to follow study instructions Additional inclusion criteria also apply Exclusion Criteria: Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study). Use of contact lenses during the study. Use of any concomitant topical ocular medications except for artificial tears during the dosing period Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents. Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye. A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation Known hypersensitivity to any component of the study drug or procedural medications Participation in any other clinical trial within 30 days prior to screening Known hypersensitivity to NSAIDS Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK) Cataract surgery within the past year. Known contraindication to the study drugs or any of their components

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 of Bromfenac in DuraSite<br> | Drug: ISV 101<br>* Bromfenac in DuraSite<br>|
| Experimental: Dose 2 of Bromfenac in DuraSite<br> | Drug: ISV 101<br>* Bromfenac in DuraSite<br>|
| Experimental: Dose 3 of Bromfenac in DuraSite<br> | Drug: ISV 101<br>* Bromfenac in DuraSite<br>|
| Active Comparator: DuraSite<br> | Drug: ISV 101<br>* Bromfenac in DuraSite<br>|
| Active Comparator: Vehicle<br> | Drug: ISV 101<br>* Bromfenac in DuraSite<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Corneal Fluorescein Staining |  | Week 8 | 
| Improvement in OSDI Scoring |  | Week 8 | 

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