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

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: NCT01076998
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Lubricant eye drop FID 115958D Other: Refresh PM Ointment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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

U.S. FDA Resources

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: Refresh PM Ointment
Refresh PM Ointment
Other: Refresh PM Ointment
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Responsible Party: Alcon Research Identifier: NCT01076998     History of Changes
Other Study ID Numbers: C-09-059
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry eye
artificial tears

Additional relevant MeSH terms:
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents