Residence Time Evaluation of Marketed OTC Ophthalmic Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804791
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Other: Systane Ultra Lubricant Eye Drops Other: Unisol 4 Saline Solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Systane
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Systane
One drop dispensed into each eye
Other: Systane Ultra Lubricant Eye Drops
artificial tears solution for lubricating the cornea
Active Comparator: Unisol
One drop dispensed into each eye
Other: Unisol 4 Saline Solution
saline solution for irrigating the cornea

Primary Outcome Measures :
  1. Ocular Surface Residence Time [ Time Frame: After 8 minutes, then every 2 minutes ]
    Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Alcon Research Identifier: NCT00804791     History of Changes
Other Study ID Numbers: M-08-11
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
dry eye
residence time

Additional relevant MeSH terms:
Pharmaceutical Solutions
Lubricant Eye Drops
Ophthalmic Solutions