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Residence Time Evaluation of Marketed OTC Ophthalmic Products

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: December 5, 2008
Last updated: January 31, 2012
Last verified: January 2012
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 Other: Systane Ultra Lubricant Eye Drops Other: Unisol 4 Saline Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.

Enrollment: 25
Study Start Date: November 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research Identifier: NCT00804791     History of Changes
Other Study ID Numbers: M-08-11
Study First Received: December 5, 2008
Last Updated: January 31, 2012

Keywords provided by Alcon Research:
dry eye
residence time

Additional relevant MeSH terms:
Pharmaceutical Solutions
Lubricant Eye Drops
Ophthalmic Solutions processed this record on September 20, 2017