Overview

Soothe Versus Refresh

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the ocular efficacy and safety of Soothe and Refresh Tears.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmaceutical Research Network
Criteria
Inclusion Criteria:

- adults with a diagnosis of dry eyes

- Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at
least one eye

- a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same
qualifying eye as the Schirmer's test

Exclusion Criteria:

- contact lens use during the active treatment periods of the trial

- history of Sjogren's Syndrome

- temporary punctal occlusion that is still effective

- the current or anticipated use during the study of punctual plugs

- current treatment with Restasis