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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Kuopio, Finlândia, 70200
- Kuopio University Hospital, Department of Ophthalmology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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
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Experimental: Group 2: Cis-UCA 2.5% 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
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Comparador de Placebo: 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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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IER (Institute of Eye Research) grading scale evaluates bulbar conjunctival redness, lid redness and corneal staining and extent
Prazo: 36 days
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36 days
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Ocular comfort rating
Prazo: 36 days
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36 days
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Early Treatment Diabetic Retinopathy Study table, a visual acuity test
Prazo: 36 days
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36 days
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Anterior chamber cells and flare using SUN Working Group Grading Schemes
Prazo: 36 days
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36 days
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Ocular pressure
Prazo: 36 days
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36 days
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Schirmer's test
Prazo: 36 days
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36 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kai Kaarniranta, Professor, Kuopio University Hospital, Department of Ophthalmology
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CL11001
- 2011-004283-30 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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