Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01252121
First received: November 30, 2010
Last updated: October 26, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.


Condition Intervention
Dry Eye Syndrome
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears 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: Time to event ] [ Designated as safety issue: No ]
    Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.


Enrollment: 27
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Systane, Hialid, Unisol
1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
Other: Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
Other: Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
Other: Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.
Systane, Unisol, Hialid
1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
Other: Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
Other: Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
Other: Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.
Hialid, Systane, Unisol
1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
Other: Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
Other: Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
Other: Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.
Hialid, Unisol, Systane
1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
Other: Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
Other: Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
Other: Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.
Unisol, Systane, Hialid
1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
Other: Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
Other: Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
Other: Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.
Unisol, Hialid, Systane
1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
Other: Systane Ultra Lubricant Eye Drops
One drop in study eye, one time, during office visit.
Other: Hialid 0.1 Artificial Tears Eye Drops
One drop in study eye, one time, during office visit.
Other: Unisol 4 Saline Solution
One drop in study eye, one time, during office visit.

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with mild to moderate dry eye as defined in the protocol.
  • Able and willing to follow instructions.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any medical condition that may affect the results of the study.
  • History or evidence of ocular or intraocular surgery within the past six months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • Use of concomitant topical ocular medications during the study period.
  • Ocular conditions that may preclude safe administration of the test article.
  • Unwilling to discontinue contact lens wear during the study period.
  • Participation in an investigational drug or device study within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.
  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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01252121     History of Changes
Other Study ID Numbers: RDG-10-275, CS-10-01
Study First Received: November 30, 2010
Last Updated: October 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye
Ocular Retention Time

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

ClinicalTrials.gov processed this record on September 18, 2014