Dry Eye
Conditions
Brief summary
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.
Interventions
DRUGRestasis, Optive Tears
Restasis and Optive Tears use twice daily more frequently if needed
Sponsors
Innovative Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* · Males or females \> 18 years old * Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye. * Likely to complete all study visits and able to provide informed consent
Exclusion criteria
* · Patients using Restasis® for less than 3 months. * Known contraindications to any study medication or ingredients * Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. * Other active uncontrolled ocular diseases or uncontrolled systemic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | 1 yr 3 months |
Secondary
| Measure | Time frame |
|---|---|
| dry eye symptoms | 1 yr 3 months |
Countries
United States
Outcome results
None listed