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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01165164
First received: July 16, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Dry Eye
Other: FID 115958D (lubricant eye drop)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Nighttime Use Assessment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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)


Enrollment: 89
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 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 bedtime

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01165164     History of Changes
Other Study ID Numbers: C-10-014
Study First Received: July 16, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye
artificial tears

Additional relevant MeSH terms:
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014