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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00469573
First received: May 2, 2007
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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).


Condition Intervention Phase
Dry Eye
Drug: 1. Optive
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Drug: 1. Optive
Optive 15ml- (in the eye) Instill one drop twice daily in each eye

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469573

Locations
United States, New York
South Shore Eye Care
Wantagh, New York, United States, 11793
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Jodi Luchs, MD South Shore Eye Care
  More Information

No publications provided

Responsible Party: Jodi Luchs, MD, South Shore Eye Care
ClinicalTrials.gov Identifier: NCT00469573     History of Changes
Other Study ID Numbers: 5302
Study First Received: May 2, 2007
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on April 14, 2014