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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139372
First Posted: June 8, 2010
Last Update Posted: February 2, 2012
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.

Condition Intervention
Dry Eye Other: FID 115958D (Lubricant Eye Drop)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ]

Enrollment: 96
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FID 115958D
Lubricant eye drop
Other: FID 115958D (Lubricant Eye Drop)
1 drop in each eye at least twice daily

  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01139372     History of Changes
Other Study ID Numbers: C-10-006
First Submitted: June 7, 2010
First Posted: June 8, 2010
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