Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00025818

Enrollment

290

Registered

2001-10-29

Start date

2001-05-31

Completion date

2003-03-31

Last updated

2011-05-30

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

Conditions

Arthritis, Rheumatoid, Keratoconjunctivitis Sicca, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome

Keywords

dry eyes, rheumatoid arthritis, Lupus, Sjogren's syndrome, myositis, scleroderma, autoimmune disorder

Brief summary

A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.

Interventions

DRUGOphthalmic Emulsion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Eighteen years or older * Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria: * Diagnosis of autoimmune disorder * Female 65 years of age or older

Countries

United States

Outcome results

None listed

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