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Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

NCT ID: NCT00469573

Last Updated: 2008-04-01

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1.

Group Type OTHER

1. Optive

Intervention Type DRUG

Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Interventions

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1. Optive

Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women 18 and over

* Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
* Complaint of dry eyes
* OSDI score \> 23

Exclusion Criteria

* Use of RGP or PMMA contact lenses

* Poorly fitting contact lenses
* Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
* Concurrent use of topical medications other than study medications
* Use of systemic medications with ocular drying sequelae:

* Antihistamines
* Decongestants
* Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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South Shore Eye Care

Principal Investigators

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Jodi Luchs, MD

Role: PRINCIPAL_INVESTIGATOR

South Shore Eye Care

Locations

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South Shore Eye Care

Wantagh, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5302

Identifier Type: -

Identifier Source: org_study_id