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

NCT01135511 | Completed Phase 2 Results

• 1 other identifier: A3921072
• Study Type: interventional
• Target: 285
• Locations: 2 countries
• Sites: 28

Brief Summary

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.

Conditions

Dry Eye Syndromes

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

• Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8

  Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

  Baseline, Week 8

Secondary Outcomes (20)

• Changes in Corneal Staining Scores for Study Eye From Baseline

  Baseline, Week 1, 2 and 4

• Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye

  Week 1, 2, 4 and 8

• Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline

  Baseline, Week 1, 2, 4 and 8

• Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline

  Baseline, Week 1, 2, 4 and 8

• Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline

  Baseline, Week 1, 2, 4 and 8

Other Outcomes (30)

• Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye

  Baseline, Week 4 and 8

• Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye

  Baseline, Week 4 and 8

• Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3

  Baseline, Week 4 and 8

Study Arms (5)

Treatment 1

EXPERIMENTAL

Drug: CP-690,550 Eye drops

Treatment 2

EXPERIMENTAL

Drug: CP-690,550 Eye drops

Treatment 3

EXPERIMENTAL

Drug: CP-690,550 Eye drops

Treatment 4

PLACEBO COMPARATOR

Drug: CP-690,550 Eye drops-vehicle

Treatment 5

ACTIVE COMPARATOR

Drug: Sodium Hyaluronate

Interventions

CP-690,550 Eye drops DRUG

Ophthalmic topical solution, low dose, dosed once/day, 8 weeks

Treatment 1

CP-690,550 Eye drops-vehicle DRUG

Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks

Treatment 4

Sodium Hyaluronate DRUG

Ophthalmic topical solution, dosed 6 times/day, 8 weeks

Treatment 5

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Pfizer Investigational Site

Ichinomiya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Narashino, Chiba, Japan

Location

Pfizer Investigational Site

Urayasu, Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Chiba, Japan, Japan

Location

Pfizer Investigational Site

Tokyo, Japan, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kangawa, Japan

Location

Pfizer Investigational Site

Kyoto, Kyoto, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Fuji, Shizuoka, Japan

Location

Pfizer Investigational Site

Numazu, Shizuoka, Japan

Location

Pfizer Investigational Site

Shizuoka, Shizuoka, Japan

Location

Pfizer Investigational Site

Susono, Shizuoka, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Hamura, Tokyo, Japan

Location

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Ohta-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Sumida-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Tachikawa, Tokyo, Japan

Location

Pfizer Investigational Site

Taito-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Tokyo, Japan

Location

Pfizer Investigational Site

Gwangju, 501-757, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 136-705, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 7, 2013
• Results First Posted: May 7, 2013

Record last verified: 2013-03

Locations

KR (6); JP (22)