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

This study is enrolling participants by invitation only.
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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    Tolerability (comfort) measured with Visual Analog scale (1 to 100)

Secondary Outcome Measures:
  • Acceptability Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Health Authority: United States: Institutional Review Board

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, 2016