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Pharmacodynamics of a Fixed dose combination of 0.34% tropicamide and 2.5% phenylephrine hydrochloride, eye drop, Solution
EU CTIS ID: 2024-517456-35-00
What this study is testing
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®
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 01. 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
- 18. Pseudoexfoliation, exfoliative syndrome
- 19. History of closed-angle glaucoma
- 02. Clinically significant illness or surgery within four weeks prior IMP administration
- 24. History of significant alcohol or drug abuse within one year prior to the screening visit
- 25. 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]
See the full eligibility criteria
Who can join
- 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
What rules you out
- 01. 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
- 18. Pseudoexfoliation, exfoliative syndrome
- 19. History of closed-angle glaucoma
- 02. Clinically significant illness or surgery within four weeks prior IMP administration
- 24. History of significant alcohol or drug abuse within one year prior to the screening visit
- 25. 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]
- 26. Inability to abstain from alcohol for the duration of study period
- 27. Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration
- 28. Positive alcohol breath test before each administration
- 29. 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
- 30. Participation in another clinical trial simultaneously
- 10. History of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis)
- 31. Breastfeeding women
- 32. Positive pregnancy test at screening
- 33. Females of reproductive age that had sexual intercourse with a non-sterile male partner without effective contraception within 14 days prior to drug administration
- 03. 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
- 04. 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
- 05. Clinically significant abnormal laboratory values
- 06. Unwilling to discontinue use of contact lenses on the day of a treatment visi
- 07. 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.
- 08. Pupillary abnormalities (irregular, very dark iris, iris synechiae, eye movement disorder (e.g. Nystagmus, etc.), dacryocystitis and all other pathologies of tears drainage system
- 09. Use of any ophthalmic medication except unpreserved artificial tears on the day of a treatment visit
- 11. History of ocular trauma, infection or inflammation within the last 3 months
- 20. Subjects with narrow angle prone to glaucoma precipitated by mydriatics
- 21. 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
- 22. Subject planning to receive an MAOI within 3 weeks following the end of the study.
- 23. Subjects who have received non-selective monoamine oxidase inhibitors (MAOIs) within the last 15 days
- 12. Ocular surgery or laser treatment of any kind in the study eye within 3 months
- 13. Irregularly-shaped pupil secondary to ocular trauma, intraocular surgery or congenital defect
- 14. History of neurogenic pupil disorder (e.g. Horner's syndrome, third cranial nerve palsy, Adie's pupil, Argyl Robertson syndrome, etc.).
- 15. History of iris surgery of any kind (e.g. iridotomy, iridectomy, coreoplasty)
- 16. History of previous corneal surgery; iris atrophy, traumatic mydriasis or angle recession, chronic or acute uveitis
- 17. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.