- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01871077
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Phase I Clinical Trial to Assess the Safety and Tolerability of the Ophthalmic Solution PRO-156 Over the Ocular Surface of Ophthalmologically Healthy Volunteers.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy male and female.
- Age between 18 and 40 years old at screening visit.
- Signed informed consent
Exclusion Criteria:
- Patient with one blind eye.
- Any ocular or systemic condition.
- Visual acuity of 20/100 in any eye.
- Use of ocular or systemic medication.
- Contraindications or sensitivity to any component of the study treatment.
- Contact lens users.
- Ocular surgery within the past 3 months..
- Pregnant, nursing or childbearing potential women who were not using effective contraception.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: PRO-156
Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
|
Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Visual Acuity (VA)
Tidsramme: 11 days
|
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5 |
11 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intraocular Pressure (IOP)
Tidsramme: 11 days
|
The tension of a healthy eye should be between 10 and 20 millimeters of mercury (mmHg).
In Goldman-type Applying Tonometry, the cornea is flattened, and the intraocular pressure is determined by measuring the force of application and the flattened area.
|
11 days
|
Number of Eyes With Epithelial Defects
Tidsramme: 11 days
|
the number of epithelial defects was evaluated by the application of fluorescein, Staining was performed with fluorescein which stained the degenerated cells and the mucus filaments present in the tear film.
|
11 days
|
Number of Cases With Adverse Events
Tidsramme: 11 days
|
The presence of adverse events was evaluated by the number of cases.
|
11 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mauricio Casillas, MD, Independent Clinical Research Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Ketorolac
Andre undersøgelses-id-numre
- SOPH156-0612/I
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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