Dry Eye
Conditions
Keywords
Dry eye, Visual Performance
Brief summary
Comparison of two contact lens solutions.
Interventions
OTHERSystane Ultra
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in objective vision | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of tear film evaporation | 4 weeks |
Outcome results
None listed