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NCT00469157 Clinical Trial

Refractive Surgery and Optive Compatibility Study

Dry Eye Syndromes Clinical Trial

Official title:
Refractive Surgery and Optive Compatibility Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00469157
Other study ID # 5303
Secondary ID
Status Completed
Phase Phase 4
First received May 2, 2007
Last updated April 16, 2008
Start date May 2007
Est. completion date April 2008

Study information
Verified date April 2008
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Optive
Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery

Locations
Country Name City State
United States TLC Fullerton California

Sponsors (1)
Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess compatibility 8 months No
Secondary comfort 8 months No
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