2024-517456-35-00招募中2 期
Pharmacodynamics of IMP 08P2002F0 (Fixed dose combination of 0.34% tropicamide and 2.5% phenylephrine hydrochloride, eye drop, Solution) a new ophthalmic mydriatic solution in healthy volunteers.
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary endpoint is the change in pupil diameter at 60 min from the time of first dose versus baseline, as measured with pupil photographs (central reading)
研究概览
简要总结
The objective of this pilot study is to explore pharmacodynamic effects and safety of IMP 08P2002F0 for dilation of the pupil, a solution combining two mydriatic agents tropicamide and phenylephrine hydrochloride at the concentrations of 0.34% and 2.5% respectively, versus Mydriasert®
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Wash out
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both genders, aged ≥18 at the time of signing the informed consent
- •Healthy volunteers are declared healthy based on medical history, physical examination, ophthalmological examination, Electrocardiogram (ECG), within the stated normal range; a participant with a clinical abnormality or laboratory parameter(s) outside the reference range may be included if the investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or interpretation
- •Females who participate in the study, that are at reproductive age (1) agree to undergo pregnancy tests and to use a highly effective birth control method (2) during the study. 1) A woman is considered to be with childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). 2) The following are considered as highly effective birth control methods : Established use of oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; established use of oral, injected, or implanted progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine hormone-releasing system or placement of an intrauterine device; bilateral tubal occlusion; vasectomised partner; true abstinence.
- •Subjects that, in the opinion of the investigator, are able to understand and comply with the study procedures and protocol restrictions
- •Subjects who have read, signed and dated the Informed Consent Form (ICF) prior the study initiation
排除标准
- •Hypersensitivity to the active substances or to the excipients or related class of the medicinal product. Serious hypersensitivity reactions include angioedema, anaphylaxis and exfoliative skin conditions including Stevens-Johnson syndrome
- •Pseudoexfoliation, exfoliative syndrome
- •History of closed-angle glaucoma
- •Clinically significant illness or surgery within four weeks prior IMP administration
- •History of significant alcohol or drug abuse within one year prior to the screening visit
- •Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) [1 Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40 % alcohol]
- •Inability to abstain from alcohol for the duration of study period
- •Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration
- •Positive alcohol breath test before each administration
- •Use of soft drugs (such as marijuana) within three months prior to screening or hard drugs such as crack, cocaine or heroin within one year prior to screening visit
- •Participation in another clinical trial simultaneously
- •History of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis)
- •Breastfeeding women
- •Positive pregnancy test at screening
- •Females of reproductive age that had sexual intercourse with a non-sterile male partner without effective contraception within 14 days prior to drug administration
- •Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure < 90 or >140 mmHg, seated diastolic blood pressure < 50 or > 90 mmHg or heart rate less than 50 or over 100 bpm) at screening
- •History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma
- •Clinically significant abnormal laboratory values
- •Unwilling to discontinue use of contact lenses on the day of a treatment visi
- •Current active eye disease (i.e. any disease for which topical or systemic ophthalmic medication is necessary). In case of historical eye disease, Ttopical or systemic ophthalmic medication should have been stopped for at least one month before the study.
- •Pupillary abnormalities (irregular, very dark iris, iris synechiae, eye movement disorder (e.g. Nystagmus, etc.), dacryocystitis and all other pathologies of tears drainage system
- •Use of any ophthalmic medication except unpreserved artificial tears on the day of a treatment visit
- •History of ocular trauma, infection or inflammation within the last 3 months
- •Subjects with narrow angle prone to glaucoma precipitated by mydriatics
- •Subject undergoing treatment identified as potentially interacting with the IMP, including antidepressant drugs, beta-blockers, other indirect sympathomimetics, alpha sympathomimetics (oral and/or nasal routes), dopaminergic ergot alkaloids, ergot alkaloid vasoconstrictors, selective MAOI-A, linezolid, and halogenated volatile anesthetics
- •Subject planning to receive an MAOI within 3 weeks following the end of the study.
- •Subjects who have received non-selective monoamine oxidase inhibitors (MAOIs) within the last 15 days
- •Ocular surgery or laser treatment of any kind in the study eye within 3 months
- •Irregularly-shaped pupil secondary to ocular trauma, intraocular surgery or congenital defect
- •History of neurogenic pupil disorder (e.g. Horner's syndrome, third cranial nerve palsy, Adie's pupil, Argyl Robertson syndrome, etc.).
- •History of iris surgery of any kind (e.g. iridotomy, iridectomy, coreoplasty)
- •History of previous corneal surgery; iris atrophy, traumatic mydriasis or angle recession, chronic or acute uveitis
- •Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
研究组 & 干预措施
0.34 % tropicamide/ 2.5 % phenylephrine hydrochloride
Experimental
Participants receiving 0.34 % tropicamide/ 2.5 % phenylephrine hydrochloride
干预措施: 0.34 % tropicamide/ 2.5 % phenylephrine hydrochloride (Drug)
结局指标
主要结局
The primary endpoint is the change in pupil diameter at 60 min from the time of first dose versus baseline, as measured with pupil photographs (central reading)
The primary endpoint is the change in pupil diameter at 60 min from the time of first dose versus baseline, as measured with pupil photographs (central reading)
次要结局
- Time to obtain sufficient mydriasis. (Defined as pupil diameter of 7.0 mm)
- Proportion of eyes achieving pupil diameter of 6.0 mm or greater throughout the 6 hours, at 30 min, at 1 h, at 2 h
- Proportion of eyes achieving pupil diameter of 7.0 mm or greater throughout the 6 hours, at 30 min, at 1 h, at 2 h
- Time from baseline to maximal pupil dilation
- Change in pupil diameter at other timepoints (10 min, 20 min, 30 min, 45 min, 60 min, 1 h 15, 1 h 30, 2 h, 2 h 30, 3 h, 3 h 30, 4 h, 4 h 30, 5 h, 6 h)
- Pupil size measured at 10 min, 20 min, 30 min, 45 min, 60 min, 1 h 15, 1 h 30, 2 h, 2 h 30, 3 h, 3 h 30, 4 h, 4 h 30, 5 h, 6 h
- Distribution of pupil diameters at 10 min, 20 min, 30 min, 45 min, 60 min, 1 h 15, 1 h 30, 2 h, 2 h 30, 3 h, 3 h 30, 4 h, 4 h 30, 5 h, 6 h
- Subject discomfort at the following recording times: 10 min, 30 min, 60 min, 2 h, 6 h
- Percent of subjects' study eyes with Pupil Diameter Returning to Baseline [Time Frame: throughout the 6 hours, at 3 h, 4 h, 5°h and 6 h]
- Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter [Time Frame: throughout the 6 hours, at 3 h, 4 h, 5°h and 6 h]
- Occurrence of Adverse events
- Ocular symptoms other than mydriasis
研究者
Clinical Manager
Scientific
Unither Pharmaceuticals
研究点 (2)
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