Residence Time Evaluation of Marketed OTC Ophthalmic Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00804791
First received: December 5, 2008
Last updated: January 31, 2012
Last verified: January 2012
  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
Other: Systane Ultra Lubricant Eye Drops
Other: Unisol 4 Saline Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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
Other Name: Systane Ultra Lubricant Eye Drops
Active Comparator: Unisol
One drop dispensed into each eye
Other: Unisol 4 Saline Solution
saline solution for irrigating the cornea
Other Name: Unisol 4 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00804791     History of Changes
Other Study ID Numbers: M-08-11
Study First Received: December 5, 2008
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
dry eye
autofluorescence
residence time

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014