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Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

NCT ID: NCT00399061

Last Updated: 2008-09-25

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Systane

Group Type ACTIVE_COMPARATOR

Systane, Optive, Restasis

Intervention Type DRUG

Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

2

Optive

Group Type ACTIVE_COMPARATOR

Systane, Optive, Restasis

Intervention Type DRUG

Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

3

Restasis

Group Type PLACEBO_COMPARATOR

Systane, Optive, Restasis

Intervention Type DRUG

Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

Interventions

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Systane, Optive, Restasis

Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* · Males or females \> 18 years old

* Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
* At least Grade 2 conjunctival staining
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria

* · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)

* Current use of topical cyclosporine
* Known contraindications to any study medication or ingredients
* Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
* Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
* Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
* Ocular surgery within the past 3 months,
* Active ocular allergies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Slingerlands Medical Building

Principal Investigators

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Robert Schultze, MD

Role: PRINCIPAL_INVESTIGATOR

Slingerlands Medical Building

Locations

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Dr. Schultze

Slingerlands, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5278

Identifier Type: -

Identifier Source: org_study_id