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

March 31, 2008 updated by: Innovative Medical
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Wantagh, New York, United States, 11793
        • South Shore Eye Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1.
Drug: 1. Optive
Optive 15ml- (in the eye) Instill one drop twice daily in each eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Medical

Investigators

  • Principal Investigator: Jodi Luchs, MD, South Shore Eye Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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