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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:
NCT01335126
First received: April 12, 2011
Last updated: April 13, 2011
Last verified: April 2011
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335126

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

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov 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:
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014