A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: CP-690,550; Drug: Cyclosporine; Drug: CP-690,550 Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784719

A3921034

Details and patient eligibility

About

A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of dry eye for at least 6 months.
• Signs of moderate to severe dry eye

Exclusion criteria

• Women who are nursing or pregnant
• Participation in other studies within 30 days of screening visit
• Ocular disorders that may confound interpretation of study results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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327 participants in 6 patient groups, including a placebo group

Treatment 1

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Treatment 2

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Treatment 3

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Treatment 4

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Active comparator

Active Comparator group

Treatment:

Drug: Cyclosporine

Placebo

Placebo Comparator group

Treatment:

Drug: CP-690,550 Vehicle