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

27. februar 2013 opdateret af: Pfizer

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.

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

327

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85286
        • Pfizer Investigational Site
      • Peoria, Arizona, Forenede Stater, 85381
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85032
        • Pfizer Investigational Site
    • California
      • Artesia, California, Forenede Stater, 90701
        • Pfizer Investigational Site
    • Colorado
      • Centennial, Colorado, Forenede Stater, 80112
        • Pfizer Investigational Site
    • Florida
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Pfizer Investigational Site
      • Stuart, Florida, Forenede Stater, 34994
        • Pfizer Investigational Site
      • Tamarac, Florida, Forenede Stater, 33321
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33603
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Pfizer Investigational Site
      • Morrow, Georgia, Forenede Stater, 30260
        • Pfizer Investigational Site
      • Roswell, Georgia, Forenede Stater, 30076
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40217
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Pfizer Investigational Site
    • New York
      • Lynbrook, New York, Forenede Stater, 11563
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Pfizer Investigational Site
      • High Point, North Carolina, Forenede Stater, 27262
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44115
        • Pfizer Investigational Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Pfizer Investigational Site
      • Austin, Texas, Forenede Stater, 78731
        • Pfizer Investigational Site
      • Austin, Texas, Forenede Stater, 78746
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78240
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: CP-690,550 Vehicle
Ophthalmic topical solution, dosed at least once/day, 8 weeks
Aktiv komparator: Aktiv komparator
Medicin: Cyclosporine
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
Eksperimentel: Behandling 1
Medicin: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Eksperimentel: Behandling 2
Medicin: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Eksperimentel: Behandling 3
Medicin: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Eksperimentel: Behandling 4
Medicin: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Medicin: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Systemic Adverse Events (AEs)
Tidsramme: 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.
Baseline up to Week 8
Percentage of Participants With Ocular Adverse Events (AEs)
Tidsramme: 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.
Baseline up to Week 8
Percentage of Participants With Ocular Tolerability Assessment
Tidsramme: 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).
Baseline up to Week 8
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Tidsramme: 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 millimeter (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.
Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Tidsramme: 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.
Baseline through Week 8
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Tidsramme: 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.
Baseline through Week 8
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
Tidsramme: 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.
Baseline through Week 8
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Tidsramme: 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.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Tidsramme: 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.
Baseline, Week 8
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Tidsramme: 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.
Week 1, 2, 4, 6
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Tidsramme: 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.
Week 8
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Tidsramme: 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.
Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Tidsramme: Week 1, 2, 4, 6, 8
Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Week 1, 2, 4, 6, 8
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 8
Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 8
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. 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.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 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 contains 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.
Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
Tidsramme: Week 1, 2, 4, 6, 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 contains 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.
Week 1, 2, 4, 6, 8
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 8
Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
Tidsramme: Week 1, 2, 4, 6, 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
Week 1, 2, 4, 6, 8
Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
Tidsramme: Baseline, Week 1, 2, 4, 6, 8
mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Tidsramme: Baseline, Week 8
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
Baseline, Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2008

Primær færdiggørelse (Faktiske)

1. oktober 2009

Studieafslutning (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først indsendt

3. november 2008

Først indsendt, der opfyldte QC-kriterier

3. november 2008

Først opslået (Skøn)

4. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A3921034

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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