Phase 2 N=327 Randomized Double-blind Treatment

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

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT00784719 ↗

Enrolled (actual)

327

Serious AEs

1.5%

Results posted

Apr 2013

Primary outcome: Primary: Percentage of Participants With Systemic Adverse Events (AEs) — 27.7; 8.7; 29.8; 27.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CP-690,550 (Drug); Cyclosporine (Drug); CP-690,550 Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Systemic Adverse Events (AEs)	27.7; 8.7; 29.8; 27.1; 18.8; 18.2	—
PRIMARY Percentage of Participants With Ocular Adverse Events (AEs)	25.5; 21.7; 31.9; 22.9; 22.9; 22.7	—
PRIMARY Percentage of Participants With Ocular Tolerability Assessment	55.6; 50.0; 53.2; 52.1; 46.8; 69.8	—
PRIMARY Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8	20.0; 17.8; 25.5; 18.8; 26.1; 27.3	—
SECONDARY Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia	NA; NA; 59.00; 58.00; NA; 57.00	—
SECONDARY Time to Achieve 100 Percent (%) Clearance of Corneal Staining	NA; NA; NA; NA; NA; NA	—
SECONDARY Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score	15.00; 8.50; 15.00; 9.50; 9.00; 15.00	—
SECONDARY Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8	4.15; 4.40; 4.02; 3.77; 4.43; 4.40	—
SECONDARY Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8	6.56; 7.58; 6.63; 6.67; 7.85; 7.92	—
SECONDARY Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6	20.0; 9.1; 6.4; 14.9; 11.6; 16.7	—
SECONDARY Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8	32.6; 27.9; 48.9; 31.3; 24.4; 25.6	—
SECONDARY Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8	6.64; 5.63; 5.83; 6.73; 6.21; 6.36	—
SECONDARY Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining	2.2; 0.0; 0.0; 0.0; 0.0; 4.8	—
SECONDARY Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8	2.77; 2.17; 2.21; 2.38; 2.17; 1.91	—
SECONDARY Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8	3.50; 3.96; 4.32; 4.65; 4.12; 3.90	—
SECONDARY Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8	45.0; 43.9; 44.8; 46.0; 45.4; 42.3	—
SECONDARY Percentage of Participants With >= 5 Units Decrease in Total OCI Score	44.4; 53.3; 38.3; 53.2; 56.8; 43.9	—
SECONDARY Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8	3.4; 3.0; 3.0; 2.5; 3.0; 2.8	—
SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8	37.6; 35.6; 31.5; 41.8; 37.8; 35.6	—
SECONDARY Percentage of Participants With >= 10 Units Decrease in Total OSDI Score	37.8; 37.8; 34.8; 46.8; 45.5; 40.0	—
SECONDARY Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8	—	—
SECONDARY Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8	—	—
SECONDARY Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8	65.22; 66.85; 62.77; 66.15; 59.90; 66.86	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00784719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.