Pharmacodynamics of a Fixed dose combination of 0.34% tropicamide and 2.5% phenylephrine hydrochloride, eye drop, Solution

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unither Pharmaceuticals

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Eye Diseases [C11]

Trial duration

8 Oct 2025 → 5 Jan 2026

Decision date (initial)

2025-06-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Pharmacodynamic

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®

Secondary objectives 1

1. Safety profile of IMP 08P2002F0 in comparison with Mydriasert®

Conditions and MedDRA coding

to obtain pre-operative mydriasis or for diagnostic purposes

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Danish Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Healthy volunteers of both genders, aged ≥18 at the time of signing the informed consent
2. 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 (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.
4. Subjects that, in the opinion of the investigator, are able to understand and comply with the study procedures and protocol restrictions
5. Subjects who have read, signed and dated the Informed Consent Form (ICF) prior the study initiation

Exclusion criteria 33

1. 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
2. 10. History of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis)
3. 11. History of ocular trauma, infection or inflammation within the last 3 months
4. 12. Ocular surgery or laser treatment of any kind in the study eye within 3 months
5. 13. Irregularly-shaped pupil secondary to ocular trauma, intraocular surgery or congenital defect
6. 14. History of neurogenic pupil disorder (e.g. Horner's syndrome, third cranial nerve palsy, Adie's pupil, Argyl Robertson syndrome, etc.).
7. 15. History of iris surgery of any kind (e.g. iridotomy, iridectomy, coreoplasty)
8. 16. History of previous corneal surgery; iris atrophy, traumatic mydriasis or angle recession, chronic or acute uveitis
9. 17. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis).
10. 18. Pseudoexfoliation, exfoliative syndrome
11. 19. History of closed-angle glaucoma
12. 02. Clinically significant illness or surgery within four weeks prior IMP administration
13. 24. History of significant alcohol or drug abuse within one year prior to the screening visit
14. 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]
15. 26. Inability to abstain from alcohol for the duration of study period
16. 27. Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration
17. 28. Positive alcohol breath test before each administration
18. 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
19. 30. Participation in another clinical trial simultaneously
20. 31. Breastfeeding women
21. 32. Positive pregnancy test at screening
22. 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
23. 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
24. 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
25. 05. Clinically significant abnormal laboratory values
26. 06. Unwilling to discontinue use of contact lenses on the day of a treatment visi
27. 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.
28. 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
29. 09. Use of any ophthalmic medication except unpreserved artificial tears on the day of a treatment visit
30. 20. Subjects with narrow angle prone to glaucoma precipitated by mydriatics
31. 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
32. 22. Subject planning to receive an MAOI within 3 weeks following the end of the study.
33. 23. Subjects who have received non-selective monoamine oxidase inhibitors (MAOIs) within the last 15 days

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 12

1. Time to obtain sufficient mydriasis. (Defined as pupil diameter of 7.0 mm)
2. 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
3. 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
4. Time from baseline to maximal pupil dilation
5. 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)
6. 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
7. 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
8. Subject discomfort at the following recording times: 10 min, 30 min, 60 min, 2 h, 6 h
9. 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]
10. 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]
11. Occurrence of Adverse events
12. Ocular symptoms other than mydriasis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unither Pharmaceuticals

Sponsor organisation

Unither Pharmaceuticals

Address

3 Rue Saint Georges

City

Paris

Postcode

75009

Country

France

Scientific contact point

Organisation

Unither Pharmaceuticals

Contact name

Clinical Manager

Public contact point

Organisation

Unither Pharmaceuticals

Contact name

Clinical Manager

Third parties 3

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications