Text Size

Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00756093
First received: September 17, 2008
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients


Condition Intervention
Dry Eye
 Other: Systane Ultra Lubricant Eye Drops
Other: Optive Lubricant Eye Drops
Other: Blink Tears
Other: GenTeal Moderate Lubricant Eye Drops

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Drop Comfort [ Time Frame: once upon instillation ] [ Designated as safety issue: No ]
    Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.


Enrollment: 20
Study Start Date: September 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops 1 drop each one time
 Other: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops one drop each eye one time
Active Comparator: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye one time
 Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops one drop each eye one time
Active Comparator: Blink Tears
Blink Tears 1 drop each eye one time
 Other: Blink Tears
Blink Tears one drop each eye one time
Active Comparator: GenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time
 Other: GenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops one drop each eye one time

  Eligibility

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

Inclusion Criteria:

  • documented diagnosis of dry eye

Exclusion Criteria:

  • use of topical ocular drops within 2 hours preceding enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756093

Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00756093     History of Changes
Other Study ID Numbers: M-08-10
Study First Received: September 17, 2008
Results First Received: September 25, 2009
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye, Artificial Tears,

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 June 18, 2013