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NCT00399230 Clinical Trial

A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00399230
Other study ID # 5279
Secondary ID
Status Completed
Phase Phase 4
First received November 9, 2006
Last updated August 17, 2007

Study information
Verified date August 2007
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to severe dry eye disease.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- · Dry eye disease diagnosis

- Patients must currently be using Systane tears at least once a day and for at least 1 month.

- Normal lid position and closure

- Male or female of legal age of consent

- Informed consent has been obtained

- Likely to complete all required follow-up visits

Exclusion Criteria:

- · Concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study.

- Subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Optive

Locations
Country Name City State
United States Dr. Rajpal McLean Virginia

Sponsors (1)
Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

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