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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01076998
First received: February 18, 2010
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.


Condition Intervention
Dry Eye
 Other: Lubricant eye drop FID 115958D
Other: Refresh PM Ointment

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Three-minute visual blur profile [ Time Frame: Through 3 minutes (post-instillation) ] [ Designated as safety issue: No ]
  • Overall Acceptability [ Time Frame: Immediately upon instillation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drop Comfort Upon Instillation [ Time Frame: Immediately upon installation ] [ Designated as safety issue: No ]

Enrollment: 24
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: Refresh PM Ointment
Refresh PM Ointment
 Other: Refresh PM Ointment
1 drop in each eye, one time

  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

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01076998     History of Changes
Other Study ID Numbers: C-09-059
Study First Received: February 18, 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:
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 June 17, 2013