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Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
Information provided by:
Hom, Milton M., OD, FAAO Identifier:
First received: April 12, 2011
Last updated: April 13, 2011
Last verified: April 2011
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Condition Intervention Phase
Dry Eye
Other: Emulsion type artificial tear
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

Resource links provided by NLM:

Further study details as provided by Hom, Milton M., OD, FAAO:

Primary Outcome Measures:
  • Tolerability Questionnaire [ Time Frame: 8 weeks ]
    Tolerability (comfort) measured with Visual Analog scale (1 to 100)

Secondary Outcome Measures:
  • Acceptability Questionnaire [ Time Frame: 8 weeks ]
    Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree)

  • Tear Break Up Time [ Time Frame: 2-3 weeks ]
    Tear Break Up Time measured in seconds

Estimated Enrollment: 48
Study Start Date: March 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Other: Emulsion type artificial tear
2 types of artificial tears


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Between the ages of 18 and over inclusive.
  • Males or females
  • Patient is in generally good & stable overall health.
  • Patient likely to comply with study guidelines & study visits.
  • Informed consent signed.
  • OSDI score >18 OR
  • TBUT <10 seconds

Exclusion Criteria:

  • Corneal refractive surgery or contact lens wear within 6 months of this study.
  • Current use of Restasis
  • Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
  • Pregnant or lactating women.
  • Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01335126

Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Principal Investigator: Milton M Hom, OD FAAO Private Practice
  More Information

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice Identifier: NCT01335126     History of Changes
Other Study ID Numbers: AG9965-007
Study First Received: April 12, 2011
Last Updated: April 13, 2011

Keywords provided by Hom, Milton M., OD, FAAO:
Artificial tears

Additional relevant MeSH terms:
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions processed this record on May 25, 2017