Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: February 18, 2010
Last updated: January 31, 2012
Last verified: January 2012
The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

Condition Intervention
Dry Eye
Other: Lubricant eye drop FID 115958D
Other: GenTeal Gel

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

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Three-minute visual blur profile [ Time Frame: Through 3 minutes (post-instillation) ] [ Designated as safety issue: No ]
  • Overall Acceptability [ Time Frame: Immediately upon instillation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drop Comfort Upon Instillation [ Time Frame: Immediately upon installation ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubricant eye drop
Lubricant eye drop
Other: Lubricant eye drop FID 115958D
1 drop in each eye, one time
Active Comparator: GenTeal Gel
GenTeal Gel
Other: GenTeal Gel
1 drop in each eye, one time


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

Inclusion Criteria:

  • Documented diagnosis of dry eye

Exclusion Criteria:

  • Must not have worn contact lenses within 12 hours preceding enrollment
  • Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research Identifier: NCT01077011     History of Changes
Other Study ID Numbers: C-09-060 
Study First Received: February 18, 2010
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:
Lubricant Eye Drops
Ophthalmic Solutions
Autonomic Agents
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Physiological Effects of Drugs
Respiratory System Agents
Vasoconstrictor Agents processed this record on May 25, 2016