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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on October 21, 2014