Clinical trial • Phase IV • Ophthalmology
TAFLUPROST for Exfoliation glaucoma | Ocular hypertension | Glaucoma
Phase IV trial of TAFLUPROST for Exfoliation glaucoma | Ocular hypertension | Glaucoma.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Exfoliation glaucoma | Ocular hypertension | Glaucoma
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-12-2024
- First CTIS Authorization Date
- 19-12-2024
Trial design
Randomised, selective laser trabeculoplasty (slt) versus taflotan® (tafluprost) ophthalmic solution (eye drops). (taflotan product present in trial documents; no detailed dosing schedule specified in available data; product metadata lists maxdailydoseamount 0.45 µg.)-controlled Phase IV trial across 1 site in Finland.
- Randomised
- Yes
- Comparator
- Selective laser trabeculoplasty (SLT) versus Taflotan® (tafluprost) ophthalmic solution (eye drops). (Taflotan product present in trial documents; no detailed dosing schedule specified in available data; product metadata lists maxDailyDoseAmount 0.45 µg.)
- Target Sample Size
- 112
- Trial Duration For Participant
- 365
Eligibility
Recruits 112 No vulnerable population selected. Inclusion criterion requires 'Informed consent'. Participants are adults aged 50–100 years. No assent or minor consent procedures are mentioned..
- Vulnerable Population
- No vulnerable population selected. Inclusion criterion requires 'Informed consent'. Participants are adults aged 50–100 years. No assent or minor consent procedures are mentioned.
Inclusion criteria
- {"criterion_text":"- Informed consent\n- Age of 50 –100 years\n- Possibility to attend 12 months of period\n- Exfoliation\n- Newly diagnosed exfoliation glaucoma by EGS (European glaucoma society) guidelines or ocular hypertensio TA 24 mmHg or more\n- Eye pressure less than 35 mmHg"}
Exclusion criteria
- {"criterion_text":"- Advanced glaucoma\n- Target IOP less than 15\n- Starting eye pressure 35 or more\n- Visual acuity 0.2 or worse\n- Angle closure\n- Unable to use eye drops\n- Significant cataract\n- Other active eye disease (active uveitis, clinical significant macular edema, wet AMD, proliferative diabetic retinopathy, intraocular tumor, intraocular injections, IOL luxation)\n- Previous intraocular operation excluding uncomplicated cataracta surgery 1 year ago or earlier\n- Serious other medical condition preventing participation in the trial\n- Participating in other clinical trial"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary end point is acceleration of the treatment by adding eye drops.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 121
- Consent Approach
- Informed consent is required from participants (Inclusion criterion: 'Informed consent'). Subject information and informed consent form documents are listed in the application, but the content (languages, age-specific documents) is not available in the provided data.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 112
Finland
- Earliest CTIS Part Ii Submission Date
- 07-12-2024
- Latest Decision Or Authorization Date
- 19-12-2024
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 112
Sites
- Site Name
- HUS-Yhtymae, Haartmaninkatu 4, Helsinki
- Department Name
- Department of Ophthalmology
- Principal Investigator Name
- Mika Harju
- Principal Investigator Email
- mika.harju@hus.fi
- Contact Person Name
- Mika Harju
- Contact Person Email
- mika.harju@hus.fi
- Number Of Participants
- 112
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Taflotan® 15 mikrogrammaa/ml silmätipat, liuos kerta-annospipetissä
- Active Substance
- TAFLUPROST
- Modality
- Small molecule
- Routes Of Administration
- Ophthalmic
- Route
- Ophthalmic
- Authorisation Status
- Authorised (marketing authorisation information present in product metadata; authorisationCountryCode: FI, mrpNumber: DE/H/0991/02)
- Maximum Dose
- 0.45 µg per day
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