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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Systane, Optive, Restasis

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr. Schultze

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Systane

Optive

Restasis

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Dry eye symptoms

Full Information

NCT ID

NCT00399061

First Posted

November 9, 2006

Last Updated

September 23, 2008

Sponsor

Innovative Medical

1. Study Identification

Unique Protocol Identification Number

NCT00399061

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Innovative Medical

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Systane

Arm Title

Arm Type

Active Comparator

Arm Description

Optive

Arm Title

Arm Type

Placebo Comparator

Arm Description

Restasis

Intervention Type

Drug

Intervention Name(s)

Systane, Optive, Restasis

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy

Time Frame

1 yr 3 months

Secondary Outcome Measure Information:

Title

Dry eye symptoms

Time Frame

1yr 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Schultze, MD

Organizational Affiliation

Slingerlands Medical Building

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Schultze

City

Slingerlands

State/Province

New York

ZIP/Postal Code

12159

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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