Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

27 lutego 2013 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

327

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Lek: CP-690,550 Vehicle
Ophthalmic topical solution, dosed at least once/day, 8 weeks
Aktywny komparator: Aktywny komparator
Lek: Cyclosporine
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
Eksperymentalny: Leczenie 1
Lek: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Eksperymentalny: Leczenie 2
Lek: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Eksperymentalny: Leczenie 3
Lek: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Eksperymentalny: Leczenie 4
Lek: CP-690,550
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Lek: CP-690,550
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Systemic Adverse Events (AEs)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2008

Zakończenie podstawowe (Rzeczywisty)

1 października 2009

Ukończenie studiów (Rzeczywisty)

1 października 2009

Daty rejestracji na studia

Pierwszy przesłany

3 listopada 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 listopada 2008

Pierwszy wysłany (Oszacować)

4 listopada 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

9 kwietnia 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lutego 2013

Ostatnia weryfikacja

1 lutego 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A3921034

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zespoły suchego oka

Badania kliniczne na CP-690,550

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Poland

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj