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NCT01335126 Clinical Trial

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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01335126
Other study ID # AG9965-007
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received April 12, 2011
Last updated April 13, 2011
Start date March 2011
Est. completion date November 2011

Study information
Verified date April 2011
Source Hom, Milton M., OD, FAAO
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 48
Est. completion date November 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Emulsion type artificial tear
2 types of artificial tears

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hom, Milton M., OD, FAAO Allergan

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerability Questionnaire Tolerability (comfort) measured with Visual Analog scale (1 to 100) 8 weeks No
Secondary Acceptability Questionnaire Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree) 8 weeks No
Secondary Tear Break Up Time Tear Break Up Time measured in seconds 2-3 weeks No
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