A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: CP-690,550 Eye drops-vehicle; Drug: Sodium Hyaluronate; Drug: CP-690,550 Eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135511

A3921072

Details and patient eligibility

About

The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.

Enrollment: 285 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjective symptoms of dry eye for at least 6 months
• Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)

Exclusion criteria

• Women who are nursing, pregnant or planning pregnancy during the study
• 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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285 participants in 5 patient groups, including a placebo group

Treatment 1

Experimental group

Treatment:

Drug: CP-690,550 Eye drops

Drug: CP-690,550 Eye drops

Drug: CP-690,550 Eye drops

Treatment 2

Experimental group

Treatment:

Drug: CP-690,550 Eye drops

Drug: CP-690,550 Eye drops

Drug: CP-690,550 Eye drops

Treatment 3

Experimental group

Treatment:

Drug: CP-690,550 Eye drops

Drug: CP-690,550 Eye drops

Drug: CP-690,550 Eye drops

Treatment 4

Placebo Comparator group

Treatment:

Drug: CP-690,550 Eye drops-vehicle

Treatment 5

Active Comparator group

Treatment:

Drug: Sodium Hyaluronate