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

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ClinicalTrials.gov Identifier: NCT01335126
Recruitment Status : Unknown
Verified April 2011 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
First Posted : April 14, 2011
Last Update Posted : April 14, 2011
Sponsor:
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO

Brief Summary:
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Emulsion type artificial tear Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
Study Start Date : March 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test Other: Emulsion type artificial tear
2 types of artificial tears



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


Secondary Outcome Measures :
  1. 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)

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



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335126


Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Allergan
Investigators
Principal Investigator: Milton M Hom, OD FAAO Private Practice

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01335126     History of Changes
Other Study ID Numbers: AG9965-007
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions