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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01139372
First received: June 7, 2010
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01139372     History of Changes
Other Study ID Numbers: C-10-006
Study First Received: June 7, 2010
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye, artificial tears

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013