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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01335126
First Posted: April 14, 2011
Last Update Posted: April 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01335126     History of Changes
Other Study ID Numbers: AG9965-007
First Submitted: April 12, 2011
First Posted: April 14, 2011
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