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

Allergan

Status and phase: Completed; Phase 3

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

Treatments: Drug: Ophthalmic Emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00025818

192371-011-01

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind