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Acute Comfort of Lubricant Eye Drops FID 112903

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00673855
First received: May 2, 2008
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

To evaluate the acute comfort and blurring profile between two artificial tears in dry eye patients.


Condition Intervention
Dry Eye
 Other: Lubricant Eye Drops FID 112903
Other: Optive Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 Upon Instillation [ Time Frame: Three minutes ] [ Designated as safety issue: No ]
    Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.


Enrollment: 20
Study Start Date: May 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubricant Eye Drops FID 112903
Lubricant Eye Drops FID 112903 1 drop each eye one time
 Other: Lubricant Eye Drops FID 112903
Lubricant Eye Drops FID 112903 1 drop each eye 1 time
Active Comparator: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye 1 time
 Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops

  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
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

  • Age related
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673855

Locations
United States, Texas
Mansfield
Mansfield, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00673855     History of Changes
Other Study ID Numbers: C-07-17
Study First Received: May 2, 2008
Results First Received: September 10, 2009
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye
Artificial tear

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 May 16, 2013