Dry Eye, Dry Eye Syndromes
Conditions
Brief summary
The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.
Interventions
DRUGRohto Dry-Aid®
DRUGSystane® Ultra
Sponsors
The Mentholatum Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age * Provide written informed consent * Have a reported history of dry eye * Have a history of use of eye drops for dry eye symptoms * Ocular discomfort * Conjunctival redness * Tear film break up time * Corneal and Conjunctival Staining
Exclusion criteria
* Have any clinically significant slit lamp findings at entry visit * Be diagnosed with an ongoing ocular infection * Have any planned ocular and/or lid surgeries over the study period * Have an uncontrolled systemic disease * Be a woman who is pregnant, nursing or planning a pregnancy * Be a woman of childbearing potential who is not using an acceptable means of birth control * Have a known allergy and/or sensitivity to the test article or its components * Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dry Eye Symptom Questionnaire | 28 days | Symptom assessment questionnaire |
| Tear Film Break Up Time | 28 days | Tear Film Break Up Time after instillation of fluorescein dye |
| Dry Eye Staining | 28 days | Dry eye syndrome corneal and conjunctival staining assessment |
| Visual Function Assessment | 28 days | Reading Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 28 Days | Adverse Event queries |
| Drop Comfort Assessment | Day 1 | The comfort of the eye drop will be performed to assess changes from baseline |
| Visual Acuity | 28 Days | Visual Acuity will be measured using the EDTRS chart to assess changes from baseline |
| Slit-Lamp Biomicroscopy | 28 Days | Slit lamp biomicroscopy exams will be performed to assess any changes from baseline |
Countries
United States
Outcome results
None listed