COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01077011
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Other: Lubricant eye drop FID 115958D Other: GenTeal Gel Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Three-minute visual blur profile [ Time Frame: Through 3 minutes (post-instillation) ]
  2. Overall Acceptability [ Time Frame: Immediately upon instillation ]

Secondary Outcome Measures :
  1. Drop Comfort Upon Instillation [ Time Frame: Immediately upon installation ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Publications of Results:

Layout table for additonal information
Responsible Party: Alcon Research Identifier: NCT01077011    
Other Study ID Numbers: C-09-060
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: January 2012
Keywords provided by Alcon Research:
Dry eye
artificial tears
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions