NCT00399230

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

August 21, 2007

Status Verified

August 1, 2007

First QC Date

November 9, 2006

Last Update Submit

August 17, 2007

Conditions

Interventions

OptiveDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · 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

You may not qualify if:

  • · 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Rajpal

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Rajesh Rajpal, MD

    See Clearly Vision Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 14, 2006

Last Updated

August 21, 2007

Record last verified: 2007-08

Locations