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Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077011
First Posted: February 26, 2010
Last Update Posted: November 21, 2016
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 compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

Condition Intervention
Dry Eye Other: Lubricant eye drop FID 115958D Other: GenTeal Gel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Three-minute visual blur profile [ Time Frame: Through 3 minutes (post-instillation) ]
  • Overall Acceptability [ Time Frame: Immediately upon instillation ]

Secondary Outcome Measures:
  • Drop Comfort Upon Instillation [ Time Frame: Immediately upon installation ]

Enrollment: 25
Study Start Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubricant eye drop
Lubricant eye drop
Other: Lubricant eye drop FID 115958D
1 drop in each eye, one time
Active Comparator: GenTeal Gel
GenTeal Gel
Other: GenTeal Gel
1 drop in each eye, one time

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Exclusion Criteria:

  • Must not have worn contact lenses within 12 hours preceding enrollment
  • Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01077011     History of Changes
Other Study ID Numbers: C-09-060
First Submitted: February 18, 2010
First Posted: February 26, 2010
Last Update Posted: November 21, 2016
Last Verified: January 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