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

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: 1. Optive

• Registration Number: NCT00469573
• Lead Sponsor: Innovative Medical

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-02
• Study First Posted: 2007-05-04
• Status Verified: 2008-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2008-03-31
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.	1. Optive	-

Primary Outcome Measures

Name	Time	Method
Safety	8 months

Secondary Outcome Measures

Name	Time	Method
Efficacy	8 months

Trial Locations

Locations (1)

South Shore Eye Care; 🇺🇸 Wantagh, New York, United States