Soothe Versus Refresh

Pharmaceutical Research Network

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Refresh Tears; Drug: Soothe

Study type: Interventional

Funder types: Other

Identifiers

NCT00284999

PRN 05-034

Details and patient eligibility

About

To determine the ocular efficacy and safety of Soothe and Refresh Tears.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind