Pharmacodynamics of a Fixed Dose Combination of 0.34% Tropicamide and 2.5% Phenylephrine Hydrochloride, Eye Drop, Solution

Pharmacodynamics of Investigational Medicinal Product (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

The objective of this 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®

Inclusion Criteria:

• 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..

  3. Females who participate in the study, that are at reproductive age agree to undergo pregnancy tests and to use a highly effective birth control method during the study.

Exclusion Criteria:

• 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.

  • Clinically significant illness or surgery within four weeks prior IMP 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 visit.
• Current active eye disease (i.e. any disease for which topical or systemic ophthalmic medication is necessary). In case of historical eye disease, topical 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 inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis).
• History of ocular trauma, infection or inflammation within the last 3 months.
• 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).

Pseudoexfoliation, exfoliative syndrome.

• History of closed-angle glaucoma.

• 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