MydriasisPhase 1/2SOLMYD-PDNCT07075224
Pharmacodynamics of a Fixed Dose Combination of 0.34% Tropicamide and 2.5% Phenylephrine Hydrochloride, Eye Drop, Solution
A Phase 1/2 study testing IMP 08P2002F0 and Mydriasert® insert in people with Mydriasis, run by Unither Pharmaceuticals, France at 2 sites in Greece.
Trial 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® Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mydriasis
- What is being tested?
- IMP 08P2002F0 and Mydriasert® insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Nov 2025to 12 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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..
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Ophthalmiatreion Athinon
Athens, 10672
Iaso Thessalia General Clinic Private Obstetrics S.A.
Larissa, 41000
About this study
Official title: 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®
- Conditions
- Mydriasis
- Being tested
- IMP 08P2002F0, Mydriasert® insert
- Keywords
- Mydriasis, Mydriatics, Phenylephrine, Tropicamide
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP 08P2002F0Drug
Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution.
Mydriasert® insertDrug
0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| IMP 08P2002F0 first, then Mydriasert(r) | Experimental | First Intervention (6 hours of follow-up):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). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation. Receives: Drug: IMP 08P2002F0; Drug: Mydriasert® insert |
| Mydriasert® Insert first, then IMP 08P2002F0 | Experimental | First Intervention (6 hours of follow-up):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). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation. Receives: Drug: IMP 08P2002F0; Drug: Mydriasert® insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pupil Diameter at 60 Minutes From the Time of First Dose Versus Baseline, as Measured With Photo (Central Reading)
Measured: 60 minutes
Secondary outcomes (10)
Time to Obtain Sufficient Mydriasis
This endpoint represents the time to first achievement of a pupil diameter ≥7.0 mm, analyzed using Kaplan-Meier time-to-event methods.
The reported median time corresponds to the time at which 50% of eyes reached this threshold and does not indicate that all eyes had achieved a pupil diameter ≥7.0 mm at that timepoint.
While all eyes eventually reached ≥7.0 mm during the observation period (no censored observations), some did so after the 30-minute assessment reported in Outcome Measure 8.
Measured: 6 hours post dose
Proportion of Eyes Achieving Pupil Diameter of 6.0 mm or Greater
Measured: Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.
Proportion of Eyes Achieving Pupil Diameter of 7.0 mm
Measured: Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.
Time From Baseline to Maximal Pupil Dilation
Measured: 6 hours post dose
Change in Pupil Diameter at Other Timepoints
Measured: 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.
Pupil Size
Measured: At baseline, 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.
Distribution of Pupil Diameters
Measured: 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
Subject Ocular Discomfort
Healthy volunteers will be asked to respond regarding the following ocular signs after instillation of the respective IMP: irritation/burning/stinging, eye dryness, foreign body sensation, blurred vision by "yes" or "no" and to assess the severity by grading 0 = none, 1 = slight, 2 = moderate, 3 = severe, if sign(s) were noted with "yes" A higher score means a worse result.
Measured: At 10 minutes, 30 minutes, 60 minutes, 1 hour and 30 minutes, 2 hours, and 6 hours post-administration.
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Measured: Throughout the 6 hours, at 3 hours, 4 hours, 5 hours, 6 hours.
Percentage of Subjects' Study Eyes Returning to Less Than or Equal to 0.2 mm From Baseline Pupil Diameter
Measured: Throughout the 6 hours, at 3 hours, 4 hours, 5 hours, 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Nov 2025
- Primary completion9 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MydriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, Observer-masked, active-controlled, randomized cross-over phase I/II study in healthy volunteers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075224
- Sponsor's protocol ID
- UP-CLI-2023-01
- Other IDs
- 2024-517456-35-00
- Acronym
- SOLMYD-PD
- Status last verified
- May 2026
- First submitted
- 30 Jun 2025
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07075224
- Acronym / sponsor ID
- SOLMYD-PD / UP-CLI-2023-01
- Conditions
- Mydriasis
- Keywords
- Mydriasis, Mydriatics, Phenylephrine, Tropicamide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 9 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, Observer-masked, active-controlled, randomized cross-over phase I/II study in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| IMP 08P2002F0 first, then Mydriasert(r) | Experimental | Drug: IMP 08P2002F0, Drug: Mydriasert® insertFirst Intervention (6 hours of follow-up):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). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation. |
| Mydriasert® Insert first, then IMP 08P2002F0 | Experimental | Drug: IMP 08P2002F0, Drug: Mydriasert® insertFirst Intervention (6 hours of follow-up):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). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMP 08P2002F0Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution. | Drug | IMP 08P2002F0 first, then Mydriasert(r), Mydriasert® Insert first, then IMP 08P2002F0 |
| Mydriasert® insert0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride | Drug | IMP 08P2002F0 first, then Mydriasert(r), Mydriasert® Insert first, then IMP 08P2002F0 |
Primary outcome
Change in Pupil Diameter at 60 Minutes From the Time of First Dose Versus Baseline, as Measured With Photo (Central Reading)
Time frame: 60 minutes
10 secondary outcomes
Time to Obtain Sufficient Mydriasis
Time frame: 6 hours post dose
Proportion of Eyes Achieving Pupil Diameter of 6.0 mm or Greater
Time frame: Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.
Proportion of Eyes Achieving Pupil Diameter of 7.0 mm
Time frame: Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.
Time From Baseline to Maximal Pupil Dilation
Time frame: 6 hours post dose
Change in Pupil Diameter at Other Timepoints
Time frame: 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.
Pupil Size
Time frame: At baseline, 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.
Distribution of Pupil Diameters
Time frame: 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
Subject Ocular Discomfort
Time frame: At 10 minutes, 30 minutes, 60 minutes, 1 hour and 30 minutes, 2 hours, and 6 hours post-administration.
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Time frame: Throughout the 6 hours, at 3 hours, 4 hours, 5 hours, 6 hours.
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 hours, 4 hours, 5 hours, 6 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMP 08P2002F0 and Mydriasert® insert in people with Mydriasis, run by Unither Pharmaceuticals, France at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pupil Diameter at 60 Minutes From the Time of First Dose Versus Baseline, as Measured With Photo (Central Reading) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.