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Residence Time Evaluation of Marketed OTC Ophthalmic Products
This study is currently recruiting participants.
Verified by Alcon Research, December 2008
First Received: December 5, 2008   Last Updated: December 8, 2008   History of Changes
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00804791
  Purpose

The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.


Condition Intervention
Dry Eye
Drug: Systane Ultra Lubricant Eye Drops
Drug: Unisol 4 Saline Solution

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • residence time [ Time Frame: 8 minutes, then every 2 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: November 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Systane Ultra Lubricant Eye Drops
Drug: Systane Ultra Lubricant Eye Drops
artificial tears
B: Placebo Comparator
Unisol 4 Saline Solution
Drug: Unisol 4 Saline Solution
saline solution

  Eligibility

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

Inclusion Criteria:

  • Informed consent and HIPAA read, signed and dated before conducting any procedures.
  • Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).
  • Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.

Exclusion Criteria:

  • History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
  • History or evidence of serious ocular trauma in either eye w/i the past 6 months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
  • Use of concomitant topical ocular medications during the study period.
  • Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
  • Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
  • Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.
  • Participation in an investigational drug or device study w/i 30 days of entering this study.
  • Additionally, any subject may be declared ineligible for a valid medical reason.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804791

Contacts
Contact: Alcon Call Center 1-888-451-3937

Locations
United States, Texas
Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Contact: Alcon Call Center     888-451-3937        
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research ( Justin Webb, O.D.\Research Optometrist )
Study ID Numbers: M-08-11
Study First Received: December 5, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00804791     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
dry eye
autofluorescence
residence time

Study placed in the following topic categories:
Tetrahydrozoline

ClinicalTrials.gov processed this record on May 07, 2009