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Refractive Surgery and Optive Compatibility Study

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00469157
First received: May 2, 2007
Last updated: April 16, 2008
Last verified: April 2008
History of Changes
  Purpose

To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.


Condition Intervention Phase
Dry Eye Syndromes
 Drug: Optive
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Refractive Surgery and Optive Compatibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Assess compatibility [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comfort [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Drug: Optive
Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 and over
  • Patients undergoing refractive surgery

Exclusion Criteria:

  • Concurrent ocular conditions or pathology that could affect 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469157

Locations
United States, California
TLC
Fullerton, California, United States, 92831
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Loren Rude, OD TLC
  More Information

No publications provided

Responsible Party: Loren Rude, OD, TLC
ClinicalTrials.gov Identifier: NCT00469157     History of Changes
Other Study ID Numbers: 5303
Study First Received: May 2, 2007
Last Updated: April 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
compatibility of Optive after PRK or LASIK

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

ClinicalTrials.gov processed this record on May 16, 2013