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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

327

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2008

Primær fullføring (Faktiske)

1. oktober 2009

Studiet fullført (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først innsendt

3. november 2008

Først innsendt som oppfylte QC-kriteriene

3. november 2008

Først lagt ut (Anslag)

4. november 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. februar 2013

Sist bekreftet

1. februar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A3921034

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