Evaluation of the Repeated Usage of Systane Ultra Eyedrop
Phase 4
Completed
- Conditions
- Dry Eye
- Registration Number
- NCT01051804
- Lead Sponsor
- Alcon Research
- Brief Summary
Comparison of two contact lens solutions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria
-
Age 18 years or more.
-
Non contact lens wearer.
-
Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
- Score ≥13 for OSDI Questionnaire total score; AND
- Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
-
Best visual acuity of 6/9 or better in each eye.
-
Willingness to adhere to the instructions set in the clinical protocol.
-
Signature of the subject informed consent form.
Exclusion Criteria
- Use of systemic medication which might produce dry eye side effects.
- Systemic disease which might produce dry eye side effects.
- Active ocular infection.
- Use of ocular medication.
- Significant ocular anomaly.
- Previous ocular surgery
- Previous use of Restasis
- Any medical condition that might be prejudicial to the study.
- The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
- The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
- The subject, based on their knowledge, must NOT have diabetes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement in objective vision 4 weeks
- Secondary Outcome Measures
Name Time Method Measurement of tear film evaporation 4 weeks