Table of Contents
- Clinical trials overview
- What each study is testing
- Who takes part in these trials
- Trial phases and study size
- Main endpoints and results measured
- Important terms used in the trials
Clinical trials overview
The trial data show Tropicamide being used in eye research for pupil dilation, which means making the pupil larger for an eye exam or surgery.[2][4] In these studies, Tropicamide appears in trials for pre-operative use, diagnostic use, and as part of study procedures in eye disease research.[2][1][3][6]
The studies are interventional, which means the researchers give a treatment or procedure and then measure the effect.[1][2][3][4][5][6] The listed trials are in Phase 1, Phase 2, Phase 3, and Phase 1/2.[1][2][3][4][5][6]
What each study is testing
One Phase 1 study tested a fixed-dose combination of 0.34% Tropicamide and 2.5% phenylephrine hydrochloride for pupil dilation, and compared it with Mydriasert.[2] The main goal was to see the change in pupil diameter at 60 minutes after the first dose.[2]
A Phase 2 study in adults with atopic keratoconjunctivitis included Tropicamide as part of the eye-drop procedures while testing Isocyclosporin A against vehicle.[1] Its main endpoint was the mean change in ocular itching score from baseline to Week 4.[1]
Another Phase 2 study in dry eye disease also included Tropicamide in the study procedures while testing different concentrations of rhNGF eye drops against vehicle.[3] The main endpoint was the mean change in dry eye symptoms from baseline to Week 8 using the SANDE Global Score.[3]
A Phase 3 study in children with cataract examined Mydrane for eye injection during surgery, with the goal of giving enough pupil dilation so surgery could be done without mechanical dilation.[4] This study focused on both safety and effectiveness in children.[4]
In a Phase 1/2 study in retinitis pigmentosa, Tropicamide was among the eye medicines used in the study setting while researchers assessed the safety of a unilateral subretinal administration of HORA PDE6B.[5] The safety checks included eye examinations, inflammation, chorioretinal tolerance, questionnaires, vital signs, and laboratory measurements.[5]
A Phase 3 study in persistent corneal epithelial defect included Tropicamide among the study eye drops while evaluating cenegermin versus vehicle.[6] The main endpoint was complete epithelial healing at Week 4, with the result needing to stay present at Week 8.[6]
Who takes part in these trials
The patient groups are different across the studies, showing that Tropicamide appears in several eye research settings.[1][2][3][4][5][6]
Adults with atopic keratoconjunctivitis took part in the Phase 2 study of Isocyclosporin A eye drops.[1]
People needing pre-operative mydriasis or diagnostic dilation took part in the Phase 1 Tropicamide and phenylephrine study.[2]
Patients with dry eye disease were included in the Phase 2 rhNGF study.[3]
Children having cataract surgery were studied in the Mykid study of Mydrane.[4]
Patients with retinitis pigmentosa carrying PDE6B gene mutations were enrolled in the Phase 1/2 HORA PDE6B study.[5]
Patients with persistent corneal epithelial defect were included in the Phase 3 cenegermin study.[6]
Trial phases and study size
The studies cover several stages of research, from early testing to later confirmation work.[1][2][3][4][5][6]
| Trial ID | Phase | Status | Enrollment |
|---|---|---|---|
| 2024-517456-35-00 | Phase 1 | Completed | 20 |
| 2023-508907-19-00 | Phase 2 | Completed | 69 |
| 2023-507561-26-00 | Phase 2 | Completed | 317 |
| 2023-504173-21-00 | Phase 3 | Completed | 40 |
| 2024-511687-90-00 | Phase 1/2 | Completed | 23 |
| 2025-523443-35-00 | Phase 3 | Authorised | 215 |
Main endpoints and results measured
The trials measure different outcomes depending on the study goal.[1][2][3][4][5][6]
Ocular itching score was measured in the atopic keratoconjunctivitis study using a visual analogue scale, which is a simple line-based symptom score.[1]
Pupil diameter at 60 minutes was the main result in the Tropicamide and phenylephrine study.[2]
Dry eye symptom score was measured with SANDE Global Score at Week 8 in the dry eye study.[3]
Sufficient pupillary dilatation for surgery was the key result in the pediatric cataract study.[4]
Safety parameters in the retinitis pigmentosa study included eye exam findings, inflammation, chorioretinal tolerance, questionnaires, vital signs, and laboratory tests.[5]
Complete epithelial healing at Week 4, maintained at Week 8, was the main endpoint in the PCED study.[6]
Important terms used in the trials
Vehicle means the comparison product without the active study drug, used to see whether the tested treatment works better.[1][3][6] Baseline means the starting point before treatment begins.[1][2][3]
Chorioretinal tolerance means how well the retina and the layer under it can tolerate the treatment.[5] Mechanical dilation means using a tool to enlarge the pupil if eye drops do not dilate it enough.[4]
