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Soothe Versus Refresh

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00284999
Enrollment
33
Registered
2006-02-01
Start date
Unknown
Completion date
2006-08-31
Last updated
2006-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Brief summary

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

Interventions

DRUGSoothe

Sponsors

Pharmaceutical Research Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026