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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease.

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

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Percentage of Participants With Systemic Adverse Events (AEs) [ Time Frame: Baseline up to Week 8 ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
  • Percentage of Participants With Ocular Adverse Events (AEs) [ Time Frame: Baseline up to Week 8 ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
  • Percentage of Participants With Ocular Tolerability Assessment [ Time Frame: Baseline up to Week 8 ]
    Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).
  • Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8 [ Time Frame: Week 8 ]
    Schirmer test without anesthesia: wel

    Original Primary Outcome:

    • Incidence and severity of ocular adverse events [ Time Frame: 8 weeks ]
    • Incidence and severity of systemic adverse events [ Time Frame: 8 weeks ]


    Current Secondary Outcome:

    • Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia [ Time Frame: Baseline through Week 8 ]
      Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Time to Achieve 100 Percent (%) Clearance of Corneal Staining [ Time Frame: Baseline through Week 8 ]
      Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score [ Time Frame: Baseline through Week 8 ]
      OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
    • Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6, 8 ]
      Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8 [ Time Frame: Baseline, Week 8 ]
      Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6 [ Time Frame: Week 1, 2, 4, 6 ]
      Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8 [ Time Frame: Week 8 ]
      Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6, 8 ]
      Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
    • Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining [ Time Frame: Week 1, 2, 4, 6, 8 ]

      Original Secondary Outcome:

      • Tear break up time [ Time Frame: 8 weeks ]
      • Symptom questionnaire [ Time Frame: 8 weeks ]
      • Corneal staining [ Time Frame: 8 weeks ]
      • Conjunctival staining [ Time Frame: 8 weeks ]
      • Schirmer wetting [ Time Frame: 8 weeks ]


      Information By: Pfizer

      Dates:
      Date Received: November 3, 2008
      Date Started: November 2008
      Date Completion:
      Last Updated: February 27, 2013
      Last Verified: February 2013