Overview
Sponsor-declared trial summary
Glaucoma
The main objective of the trial is to show the equilance in efficacy of SLT laser treatment compared to medical therapy as a primary therapy in exfoliation glaucoma.
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2024-12-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520083-33-00
- EudraCT number
- 2019-004841-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The main objective of the trial is to show the equilance in efficacy of SLT laser treatment compared to medical therapy as a primary therapy in exfoliation glaucoma.
Conditions and MedDRA coding
Glaucoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Informed consent
- Age of 50 –100 years
- Possibility to attend 12 months of period
- Exfoliation
- Newly diagnosed exfoliation glaucoma by EGS (European glaucoma society) guidelines or ocular hypertensio TA 24 mmHg or more
- Eye pressure less than 35 mmHg
Exclusion criteria 11
- Advanced glaucoma
- Target IOP less than 15
- Starting eye pressure 35 or more
- Visual acuity 0.2 or worse
- Angle closure
- Unable to use eye drops
- Significant cataract
- Other active eye disease (active uveitis, clinical significant macular edema, wet AMD, proliferative diabetic retinopathy, intraocular tumor, intraocular injections, IOL luxation)
- Previous intraocular operation excluding uncomplicated cataracta surgery 1 year ago or earlier
- Serious other medical condition preventing participation in the trial
- Participating in other clinical trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary end point is acceleration of the treatment by adding eye drops.
Secondary endpoints 1
- Secondary end points are eye dryness and eye pressure and long term end points are cumulative success of SLT-treatment and need for glaucoma surgery.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Taflotan® 15 mikrogrammaa/ml silmätipat, liuos kerta-annospipetissä
PRD365663 · Product
- Active substance
- Tafluprost
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC
- Max daily dose
- 0.45 µg microgram(s)
- Max total dose
- 0.45 µg microgram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01EE05 — -
- Marketing authorisation
- 23420
- MA holder
- SANTEN OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Department of Ophthalmology
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Department of Ophthalmology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 112 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma SLT eksfoliaatiglaukooman primaarihoitona vs 160820 | 1 |
| Recruitment arrangements (for publication) | Selvitys tutkittavien valitsemiseen liittyvista menettelytavoista | 1 |
| Subject information and informed consent form (for publication) | Tutkittavan suostumus vs 120620 | 1 |
| Subject information and informed consent form (for publication) | Tutkittavan tiedote vs 110620 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | TAFLOTAN silmatipat liuos kertaannospakkaus 15 mikrog_ml Pharmaca Fennica | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-10 | Finland | Acceptable 2024-12-19
|
2024-12-19 |