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

NCT07075224 | Not Yet Recruiting Phase 1

• 2 other identifiers: UP-CLI-2023-012024-517456-35-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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®

Conditions

Mydriasis

Keywords

Mydriasis; Mydriatics; Phenylephrine; Tropicamide

Outcome Measures

Primary Outcomes (1)

• Change in pupil diameter at 60 minutes from the time of first dose versus baseline, as measured with photo (central reading)

  60 minutes

Secondary Outcomes (10)

• Time to obtain sufficient mydriasis

  6 hours post dose

• Proportion of eyes achieving pupil diameter of 6.0 mm or greater

  Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.

• Proportion of eyes achieving pupil diameter of 7.0 mm

  Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.

• Time from baseline to maximal pupil dilation

  6 hours post dose

• Change in pupil diameter at other timepoints

  At 10 minutes, 20 minutes, 30 minutes, 45 minutes, 60 minutes, 1 hour and 15 minutes, 1 hour and 30 minutes, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 4 hours and 30 minutes, 5 hours, 6 hours.

Other Outcomes (2)

• Occurrence of Adverse event

  Day 10 post dose

• Ocular symptoms other than mydriasis

  Day 10 post dose

Study Arms (2)

IMP 08P2002F0

EXPERIMENTAL

1 eye drop. Rinsing will be performed with NaCl 30 min after instillation

Drug: IMP 08P2002F0

Mydriasert® insert

ACTIVE COMPARATOR

1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).

Drug: Mydriasert® insert

Interventions

IMP 08P2002F0 DRUG

Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution.

IMP 08P2002F0

Mydriasert® insert DRUG

0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride

Mydriasert® insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 agree to undergo pregnancy tests and to use a highly effective birth control method during the study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Unither Pharmaceuticals, France: lead

Study Sites (2)

Ophthalmiatreion Athinon

Athens, 10672, Greece

Location

Iaso Thessalia General Clinic Private Obstetrics S.A.

Larissa, 41000, Greece

Location

MeSH Terms

Conditions

Mydriasis

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Central Study Contacts

Clinical Manager

CONTACT

+330144635178; clinicaltrials@unither-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, Observer-masked, active-controlled, randomized cross-over phase I/II study in healthy volunteers.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 20, 2025
• Study Start: July 15, 2025
• Primary Completion: September 27, 2025
• Study Completion: September 30, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)