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An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop

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ClinicalTrials.gov Identifier: NCT01139372
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.

Condition or disease Intervention/treatment
Dry Eye Other: FID 115958D (Lubricant Eye Drop)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop
Study Start Date : May 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: FID 115958D
Lubricant eye drop
Other: FID 115958D (Lubricant Eye Drop)
1 drop in each eye at least twice daily


Outcome Measures

Primary Outcome Measures :
  1. Daytime 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) [ Time Frame: Day 7 ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Documented diagnosis of dry eye
  • Current use of Refresh Liquigel, GenTeal Gel Drops or Refresh Celluvisc at least twice daily

Exclusion Criteria:

  • Must not have worn contact lenses within 7 days preceding enrollment
  • Must not have had punctal plugs inserted within 30 days preceding enrollment
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01139372     History of Changes
Other Study ID Numbers: C-10-006
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Dry eye, artificial tears

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