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
  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:


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
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: 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
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on October 20, 2014