Studie av INV-102 oftalmisk løsning hos voksne med moderat symptomatisk tørre øyesykdom
Fase 1/2, multisenter, randomisert, dobbeltmasket, kjøretøykontrollert, multippel stigende dose (del 1) og valgfri doseutvidelse (del 2) studie av INV-102 oftalmisk løsning hos voksne pasienter med moderat symptomatisk tørre øyesykdom
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Rush, New York, Forente stater, 14543
- iuvo BioScience
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
- Healthy male or female subject ≥18 years of age
- Presence of moderate DED in at least one eye
Key Exclusion Criteria:
- Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
- Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
- External eye disease except primary DED
- Systemic disease associated with DED
- History or evidence of ocular infection within the previous 30 days
- History or evidence of ocular herpes simplex or ocular herpes zoster
- Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: INV-102 0.1% Twice daily (BID)
Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Eksperimentell: INV-102 0.25% BID
Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Eksperimentell: INV-102 0.7% BID
Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Eksperimentell: INV-102 0.7% Three times daily (TID)
Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks |
INV-102 Ophthalmic Solution |
|
Eksperimentell: INV-102 TBD% BID
Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4 |
INV-102 Ophthalmic Solution |
|
Placebo komparator: Vehicle
Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks |
Vehicle Ophthalmic Solution |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event
Tidsramme: From first dose through study completion (Day 22)
|
The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens. |
From first dose through study completion (Day 22)
|
|
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)
Tidsramme: Day 15
|
The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms. |
Day 15
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score
Tidsramme: Day 15
|
The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement). |
Day 15
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Robert Shalwitz, MD, Invirsa, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- INV-102-CS-001
- 75A50120C00171 (Annet stipend/finansieringsnummer: ASPR-BARDA)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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