An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)

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: NCT01165164
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.

Condition or disease Intervention/treatment
Dry Eye Other: FID 115958D (lubricant eye drop)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: FID 115958D
Lubricant eye drop
Other: FID 115958D (lubricant eye drop)
1 drop in each eye at bedtime

Primary Outcome Measures :
  1. Nighttime Use Assessment [ Time Frame: Day 7 ]
    Nighttime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)

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:

  1. Documented diagnosis of dry eye
  2. Current use of an eye ointment or tube gel

Exclusion Criteria:

  1. No nighttime contact lenses wear throughout the study period
  2. Must not have had punctal plugs inserted within 30 days preceding enrollment

Responsible Party: Alcon Research Identifier: NCT01165164     History of Changes
Other Study ID Numbers: C-10-014
First Posted: July 19, 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