Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
Phase 3
- Conditions
- Dry Eye
- Interventions
- Other: Emulsion type artificial tear
- Registration Number
- NCT01335126
- Lead Sponsor
- Hom, Milton M., OD, FAAO
- Brief Summary
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Emulsion type artificial tear -
- Primary Outcome Measures
Name Time Method Tolerability Questionnaire 8 weeks Tolerability (comfort) measured with Visual Analog scale (1 to 100)
- Secondary Outcome Measures
Name Time Method Acceptability Questionnaire 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 2-3 weeks Tear Break Up Time measured in seconds