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- Register voor klinische proeven in de VS.
- Klinische proef NCT01476332
Safety, Tolerability and Pharmacokinetics of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers (Phase I)
A Single Dose (Part 1) and Multiple Dose (Part 2) Phase I, Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
This is a Phase I single-centre, double-blind, placebo-controlled, single and multiple dose study to evaluate safety, ocular tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in healthy volunteers for up to 15 days. After the single day dose (three times) on day 1 and the subsequent 7 (± 1) days wash-out period, a multidose phase with three times a day administration for 14 days will start
Primary objectives:
- Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on a randomized eye three times during a single day, assessed up to 7 (± 1) days following dosing in healthy volunteers
- Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on both eyes three times a day for 14 days, assessed up to 7 days following the last dosing in healthy volunteers
Secondary objectives:
- To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on a randomized eye in adult healthy volunteers
- To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on both eyes three times a day for 14 days in adult healthy volunteers
Healthy male or female volunteer, 18-65 years of age, with no history of significant eye disease or any current eye disease that would affect the pharmacokinetics of cis-UCA. Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2 of the study.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Kuopio, Finland, 70200
- Kuopio University Hospital, Department of Ophthalmology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Informed consent obtained prior to any screening procedure
- Caucasian male or female subject
- Age 18-65 y
- Weight at least 45 kg
- Corrected visual acuity > 20/25 in both eyes
- Intraocular pressure < 21 mmHg, with a difference between eyes of < 4 mmHg
- Ability to tolerate and self-administer vehicle eye drops
- Normal slit lamp examination and dilated fundoscopic examination
- Normal clinical laboratory profiles, defined as complete blood count, serum chemistry, and urinalysis values within the normal range
- Willingness to abstain from concomitant use of ocular or systemic medication (excluding oral contraceptives, ibuprofen, paracetamol, calcium preparations and vitamins) from 2 weeks prior to the start of study dosing until study completion
- Willingness to comply with study-related procedures
- Negative urine pregnancy test (premenopausal female subject) at screening and use of adequate contraceptive measures throughout the study and 30 days after the last study medication dose
- A premenopausal female subject should be either surgically sterile or using a reliable contraception method: intrauterine device; oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy)
- Subject with no current heterosexual relationship may be included according to the judgment of the Investigator
- If menopause occurred 2 years ago at the minimum, no contraception is required for a female participant, nor pregnancy test
- Reliable contraception for a male subject is concordant with above listed methods for females, as applicable
Exclusion Criteria:
- History of ocular surgery, trauma, or chronic ocular disease
- Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day
- Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales)
- Use of ocular agents (including all types of eye drops) within the past month prior to the first dosing day or anticipated use of ocular agents during the study period
- Use of systemic or inhaled nasal or pulmonary corticosteroids within the past month prior to the first dosing day
- Use of systemic antihistamines within one week prior to the first dosing day
- History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis within 2 months prior to the first dosing day; history of herpes simplex keratitis at any time
- Current ocular allergy symptoms
- Loss, donation, or removal of 400 ml or more of blood within 2 months prior to the first dosing day
- Women who are pregnant or breastfeeding, or non-sterile or premenopausal women who refuse to use two proven methods of contraception during the study and for at least 30 days following the final dose of study drug
- Participation in another clinical drug or device study within 2 months prior to the first dosing day
- Current smoking
- Current or history of drug or alcohol abuse
- Known human immunodeficiency virus- or acquired immunodeficiency syndrome -related illness.
- Allergy to cis-UCA, or any constituents of the cis-UCA eye drops (cis-urocanic acid, aqua, sodium chloride, polyvinyl alcohol, sodium hydroxide, and/or hydrochloric acid) or placebo for cis-UCA eye drops (aqua, sodium chloride, polyvinyl alcohol, sodium hydroxide, and/or hydrochloric acid)
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, would affect the subject's ability to follow study-related procedures, or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study.
- Doubtful availability to complete the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Group 1: Cis-UCA 0.5% eye drops
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one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
|
Experimenteel: Group 2: Cis-UCA 2.5% eye drops
|
one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
|
Placebo-vergelijker: Group 3: Placebo for cis-UCA, eye drops
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one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
IER (Institute of Eye Research) grading scale evaluates bulbar conjunctival redness, lid redness and corneal staining and extent
Tijdsspanne: 36 days
|
36 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Ocular comfort rating
Tijdsspanne: 36 days
|
36 days
|
Early Treatment Diabetic Retinopathy Study table, a visual acuity test
Tijdsspanne: 36 days
|
36 days
|
Anterior chamber cells and flare using SUN Working Group Grading Schemes
Tijdsspanne: 36 days
|
36 days
|
Ocular pressure
Tijdsspanne: 36 days
|
36 days
|
Schirmer's test
Tijdsspanne: 36 days
|
36 days
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kai Kaarniranta, Professor, Kuopio University Hospital, Department of Ophthalmology
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CL11001
- 2011-004283-30 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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