Dry Eye
Conditions
Brief summary
To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.
Interventions
DRUGPEG-400 based artificial tear
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
DRUGSystane
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
Sponsors
Bp Consulting, 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
Yes
Inclusion criteria
* Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD. * Physician assessment of mild-moderate dry eye * Patient willing to instill drops QID and complete entire length of protocol. * TBUT \< 10 seconds * BCVA of 20/30 or better
Exclusion criteria
* Current topical cyclosporine use (Restasis) * Current Systane use * Refractive surgery within the last 6 months * Oral or topical corticosteroid use * Severe dry eye patients by physician assessment * current active Blepharitis * Oral Doxycyclines use * Oral Antihistamine use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dry Eye Signs | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual Quality | 4 months |
Countries
United States
Outcome results
None listed