- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335126
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
April 13, 2011 updated by: Hom, Milton M., OD, FAAO
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test
|
2 types of artificial tears
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability Questionnaire
Time Frame: 8 weeks
|
Tolerability (comfort) measured with Visual Analog scale (1 to 100)
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
8 weeks
|
Tear Break Up Time
Time Frame: 2-3 weeks
|
Tear Break Up Time measured in seconds
|
2-3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Milton M Hom, OD FAAO, Private Practice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
November 1, 2011
Study Registration Dates
First Submitted
April 12, 2011
First Submitted That Met QC Criteria
April 13, 2011
First Posted (Estimate)
April 14, 2011
Study Record Updates
Last Update Posted (Estimate)
April 14, 2011
Last Update Submitted That Met QC Criteria
April 13, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG9965-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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