Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Osaka, Japan
- Santen study sites
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Provided signed, written informed consent.
- Has a positive result from an allergen-specific IgE antibody test.
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion Criteria:
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
Studieplan
Hvordan er studiet utformet?
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
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Andre navn:
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Placebo komparator: 2
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Aktiv komparator: 3
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Ocular Itching Score Compared to Placebo Period1
Tidsramme: Visit 5 (3, 5, and 10 minutes post-CAC)
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A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge . |
Visit 5 (3, 5, and 10 minutes post-CAC)
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Mean Hyperemia Score Compared to Placebo Period1
Tidsramme: Visit 5 (5, 10, and 20 minutes post-CAC)
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A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge . |
Visit 5 (5, 10, and 20 minutes post-CAC)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Ocular Itching Score Compared to Olopatadine Period2
Tidsramme: Visit 7 (3, 5, and 10 minutes post-CAC)
|
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge . |
Visit 7 (3, 5, and 10 minutes post-CAC)
|
|
Mean Hyperemia Score Compared to Olopatadine Period2
Tidsramme: Visit 7 (5, 10, and 20 minutes post-CAC)
|
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge . |
Visit 7 (5, 10, and 20 minutes post-CAC)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Overfølsomhet, Umiddelbar
- Øyesykdommer
- Overfølsomhet
- Konjunktivale sykdommer
- Konjunktivitt
- Konjunktivitt, allergisk
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Anti-allergiske midler
- Histamin H1-antagonister
- Histaminantagonister
- Histaminmidler
- Histamin H1-antagonister, ikke-sederende
- Oftalmiske løsninger
- Farmasøytiske løsninger
- Olopatadin hydroklorid
- Epinastine
Andre studie-ID-numre
- 01141101
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