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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: February 18, 2010
Last updated: January 31, 2012
Last verified: January 2012
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: 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: 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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

Responsible Party: Alcon Research Identifier: NCT01076998     History of Changes
Other Study ID Numbers: C-09-059
Study First Received: February 18, 2010
Last Updated: January 31, 2012

Keywords provided by Alcon Research:
Dry eye
artificial tears

Additional relevant MeSH terms:
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on September 19, 2017