A Phase 1/2 interventional study of IMP 08P2002F0 and Mydriasert® insert in Mydriasis, sponsored by Unither Pharmaceuticals, France. Completed at 2 sites in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Unither Pharmaceuticals, France · Phase 1/2, Interventional, and Diagnostic
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®
37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.
This study's enrollment of 20 is below the median of 61 across 35 interventional studies indexed under Mydriasis.
Browse Mydriasis studies →Unither Pharmaceuticals, France is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy volunteers are declared healthy based on medical history, physical examination, ophthalmological examination, (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 method during the study.
Exclusion Criteria:
to the active substances or to the 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.
Pseudoexfoliation, exfoliative syndrome.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: IMP 08P2002F0 · Drug: Mydriasert® insert
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.
Drug: IMP 08P2002F0 · Drug: Mydriasert® insert
Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution.
0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride
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
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.
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
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.
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.
Occurrence of Adverse Event
Time frame: Day 10 post dose
| Milestone | Mydriasert® Insert First, Then IMP 08P2002F0 | IMP 08P2002F0 First, Then Mydriasert(r) |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Mydriasert® Insert First, Then IMP 08P2002F0 | IMP 08P2002F0 First, Then Mydriasert(r) |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| millimeter | Mydriasert® Insert | IMP 08P2002F0 |
|---|---|---|
| Change in Pupil Diameter at 60 Minutes From the Time of First Dose Versus Baseline, as Measured With Photo (Central Reading) | 3.28 ± 0.95 | 3.29 ± 0.81 |
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.
| minutes | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| Time to Obtain Sufficient Mydriasis | 20 ± 0 | 30 ± 0 |
| eye | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| at 30 minutes | 20 | 19 |
| at 1 hour | 20 | 20 |
| at 2 hour | 20 | 20 |
| Throughout the 6 hours | 20 | 20 |
| eye | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| at 30 minutes | 20 | 10 |
| at 1 hour | 20 | 20 |
| at 2 hour | 20 | 20 |
| Throughout the 6 hours | 20 | 20 |
| minutes | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| Time From Baseline to Maximal Pupil Dilation | 60 (47.118 to 72.882) | 90 (84.523 to 95.477) |
| millimeter | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| at 10 minutes | 1.43 ± 0.79 | 0 ± 0.31 |
| at 20 minutes | 2.40 ± 0.82 | 0.38 ± 0.41 |
| at 30 minutes | 2.88 ± 0.90 | 1.57 ± 1.10 |
| at 45 minutes | 3.18 ± 0.91 | 2.70 ± 0.94 |
| at 1h15 | 3.31 ± 0.96 | 3.51 ± 0.84 |
| at 1h30 | 3.27 ± 0.93 | 3.65 ± 0.84 |
| at 2h | 3.14 ± 0.98 | 3.64 ± 0.88 |
| At 2h30 | 2.92 ± 1.03 | 3.61 ± 0.86 |
| at 3h | 2.65 ± 1.08 | 3.48 ± 0.88 |
| 3 h 30 min | 2.42 ± 1.10 | 3.34 ± 0.94 |
| at 4h | 2.20 ± 1.03 | 3.18 ± 0.96 |
| at 4h30 | 1.92 ± 1.04 | 2.90 ± 1.07 |
| at 5h | 1.73 ± 0.92 | 2.48 ± 1.17 |
| at 6h | 1.25 ± 0.96 | 2.00 ± 1.01 |
| at 60 min | 3.28 ± 0.95 | 3.29 ± 0.81 |
| millimeter | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| Baseline | 5.37 ± 0.76 | 5.37 ± 0.95 |
| at 10 min | 6.80 ± 0.73 | 5.36 ± 0.98 |
| at 20 min | 7.76 ± 0.58 | 5.75 ± 0.97 |
| at 30 min | 8.24 ± 0.64 | 6.94 ± 0.94 |
| At 45 min | 8.55 ± 0.66 | 8.07 ± 0.92 |
| At 60 min | 8.65 ± 0.68 | 8.66 ± 0.65 |
| at 1h15 min | 8.67 ± 0.67 | 8.88 ± 0.64 |
| at 1h30 | 8.64 ± 0.65 | 9.02 ± 0.61 |
| At 2h | 8.51 ± 0.66 | 9.01 ± 0.63 |
| At 2h30 | 8.28 ± 0.69 | 8.98 ± 0.63 |
| at 3h00 | 8.02 ± 0.75 | 8.84 ± 0.72 |
| At 3h30 | 7.78 ± 0.75 | 8.71 ± 0.83 |
| At 4h | 7.56 ± 0.77 | 8.54 ± 0.90 |
| At 4h30 | 7.29 ± 0.75 | 8.27 ± 1.00 |
| At 5h00 | 7.10 ± 0.75 | 7.85 ± 1.14 |
| At 6h00 | 6.62 ± 0.85 | 7.37 ± 1.13 |
| millimeter | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| at 10 minutes | 6.700 (5.400 to 8.100) | 5.350 (3.600 to 7.000) |
| at 20 minutes | 7.600 (6.800 to 9.200) | 5.880 (4.250 to 7.300) |
| at 30 minutes | 8.215 (7.290 to 9.700) | 6.950 (5.300 to 8.980) |
| at 45 minutes | 8.500 (7.620 to 9.800) | 8.000 (5.900 to 9.810) |
| at 60 minutes | 8.650 (7.640 to 9.800) | 8.600 (7.400 to 9.910) |
| at 1h15 | 8.520 (7.680 to 9.940) | 8.900 (7.890 to 10.230) |
| at 1h30 | 8.540 (7.600 to 9.820) | 9.050 (8.070 to 10.160) |
| At 2h | 8.470 (7.600 to 9.900) | 9.100 (7.800 to 10.070) |
| at 2h30 | 8.200 (7.300 to 9.900) | 9.100 (7.790 to 10.100) |
| at 3h | 7.950 (6.800 to 9.900) | 8.845 (7.190 to 10.000) |
| At 3h30 | 7.475 (6.900 to 9.600) | 8.700 (6.620 to 9.900) |
| At 4h00 | 7.400 (6.600 to 9.300) | 8.700 (6.040 to 9.900) |
| at 4h30 | 7.100 (6.300 to 8.900) | 8.300 (5.470 to 9.600) |
| at 5h | 6.950 (6.000 to 8.800) | 7.980 (5.300 to 9.700) |
| at 6h | 6.550 (5.200 to 8.300) | 7.550 (5.190 to 9.100) |
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.
| Participants | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| Irritation/Burning/stinging : 10 min — None | 17 | 16 |
| Irritation/Burning/stinging : 10 min — Slight | 3 | 4 |
| Irritation/Burning/stinging : 10 min — Moderate | 0 | 0 |
| Irritation/Burning/stinging : 10 min — Severe | 0 | 0 |
| Irritation/Burning/stinging : 30 min — None | 19 | 16 |
| Irritation/Burning/stinging : 30 min — Slight | 1 | 1 |
| Irritation/Burning/stinging : 30 min — Moderate | 0 | 3 |
| Irritation/Burning/stinging : 30 min — Severe | 0 | 0 |
| Irritation/Burning/stinging : 60 min — None | 18 | 14 |
| Irritation/Burning/stinging : 60 min — Slight | 2 | 4 |
| Irritation/Burning/stinging : 60 min — Moderate | 0 | 1 |
| Irritation/Burning/stinging : 60 min — Severe | 0 | 1 |
| Irritation/Burning/stinging : 2h — None | 20 | 17 |
| Irritation/Burning/stinging : 2h — Slight | 0 | 3 |
| Irritation/Burning/stinging : 2h — Moderate | 0 | 0 |
| Irritation/Burning/stinging : 2h — Severe | 0 | 0 |
| Irritation/Burning/stinging : 6h — None | 20 | 20 |
| Irritation/Burning/stinging : 6h — Slight | 0 | 0 |
| Irritation/Burning/stinging : 6h — Moderate | 0 | 0 |
| Irritation/Burning/stinging : 6h — Severe | 0 | 0 |
| Foreign body sensation 10 min — None | 19 | 8 |
| Foreign body sensation 10 min — Slight | 1 | 9 |
| Foreign body sensation 10 min — Moderate | 0 | 3 |
| Foreign body sensation 10 min — Severe | 0 | 0 |
| Foreign body sensation : 30 min — None | 20 | 10 |
| Foreign body sensation : 30 min — Slight | 0 | 7 |
| Foreign body sensation : 30 min — Moderate | 0 | 2 |
| Foreign body sensation : 30 min — Severe | 0 | 1 |
| Foreign body sensation : 60 min — None | 19 | 13 |
| Foreign body sensation : 60 min — Slight | 1 | 5 |
| Foreign body sensation : 60 min — Moderate | 0 | 1 |
| Foreign body sensation : 60 min — Severe | 0 | 1 |
| Foreign body sensation : 2h — None | 19 | 18 |
| Foreign body sensation : 2h — Slight | 1 | 2 |
| Foreign body sensation : 2h — Moderate | 0 | 0 |
| Foreign body sensation : 2h — Severe | 0 | 0 |
| Foreign body sensation : 6h — None | 20 | 19 |
| Foreign body sensation : 6h — Slight | 0 | 1 |
| Foreign body sensation : 6h — Moderate | 0 | 0 |
| Foreign body sensation : 6h — Severe | 0 | 0 |
| Blurred vision 10 min — None | 6 | 20 |
| Blurred vision 10 min — Slight | 10 | 0 |
| Blurred vision 10 min — Moderate | 4 | 0 |
| Blurred vision 10 min — Severe | 0 | 0 |
| Blurred vision 30 min — None | 1 | 9 |
| Blurred vision 30 min — Slight | 9 | 7 |
| Blurred vision 30 min — Moderate | 8 | 4 |
| Blurred vision 30 min — Severe | 2 | 0 |
| Blurred vision 60 min — None | 2 | 4 |
| Blurred vision 60 min — Slight | 9 | 7 |
| Blurred vision 60 min — Moderate | 7 | 9 |
| Blurred vision 60 min — Severe | 2 | 0 |
| Blurred vision 2h — None | 5 | 4 |
| Blurred vision 2h — Slight | 13 | 13 |
| Blurred vision 2h — Moderate | 2 | 3 |
| Blurred vision 2h — Severe | 0 | 0 |
| Blurred vision 6h — None | 19 | 15 |
| Blurred vision 6h — Slight | 1 | 5 |
| Blurred vision 6h — Moderate | 0 | 0 |
| Blurred vision 6h — Severe | 0 | 0 |
| Dry eye 10 min — None | 20 | 20 |
| Dry eye 10 min — Slight | 0 | 0 |
| Dry eye 10 min — Moderate | 0 | 0 |
| Dry eye 10 min — Severe | 0 | 0 |
| Dry Eye 30 min — None | 20 | 19 |
| Dry Eye 30 min — Slight | 0 | 0 |
| Dry Eye 30 min — Moderate | 0 | 1 |
| Dry Eye 30 min — Severe | 0 | 0 |
| Dry Eye 60 min — None | 20 | 17 |
| Dry Eye 60 min — Slight | 0 | 3 |
| Dry Eye 60 min — Moderate | 0 | 0 |
| Dry Eye 60 min — Severe | 0 | 0 |
| Dry Eye 2h — None | 20 | 20 |
| Dry Eye 2h — Slight | 0 | 0 |
| Dry Eye 2h — Moderate | 0 | 0 |
| Dry Eye 2h — Severe | 0 | 0 |
| Dry Eye 6h — None | 20 | 19 |
| Dry Eye 6h — Slight | 0 | 1 |
| Dry Eye 6h — Moderate | 0 | 0 |
| Dry Eye 6h — Severe | 0 | 0 |
| eye | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| at 3h | 0 | 0 |
| at 4h | 0 | 0 |
| At 5h | 0 | 1 |
| at 6h | 1 | 0 |
| Throughout the 6 hours | 1 | 0 |
| eye | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| at 3h | 0 | 0 |
| at 4h | 0 | 0 |
| at 5h | 0 | 1 |
| at 6h | 1 | 1 |
| Throughout 6 h | 1 | 1 |
| adverse event | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| Occurrence of Adverse Event | 0 | 1 |
Collected over 12 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IMP 08P2002F0 | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Mydriasert® Insert | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Event | IMP 08P2002F0 | Mydriasert® Insert |
|---|---|---|
| Swelling of eyelidEye disorders | — | 1/20 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 42.75 ± 15.341 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 12 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
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Unither Pharmaceuticals, France