Dry Eye Syndrome
Conditions
Keywords
RX-10045, Dry Eye Disease
Brief summary
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.
Interventions
DRUGRX-10045
One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
DRUGVehicle for RX-10045
One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
Sponsors
C.T. Development America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have a patient reported history of dry eye in both eyes 2. Presence of dry eye symptoms 3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining
Exclusion criteria
1. Known contraindications or sensitivities to study medication or its components 2. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters 3. Use of disallowed medication during the period indicated prior to the enrollment or during the study 4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal staining | Baseline to day 28 |
| Worst symptom score | Baseline to day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Ocular discomfort symptom score | Baseline to day 28 |
| Tear film break-up time | Baseline to day 28 |
| Visual-related function subscale of Ocular Surface Disease Index score | Baseline to day 28 |
Countries
United States
Outcome results
None listed