Clinical trial • Phase IV • Ophthalmology
NEPAFENAC for Cataract
Phase IV trial of NEPAFENAC for Cataract. 120 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Cataract
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-09-2024
- First CTIS Authorization Date
- 01-10-2024
Trial design
Phase IV trial across 1 site in Norway.
- Target Sample Size
- 120
Eligibility
Recruits 120 No vulnerable populations selected. Only adults (18 years and older) may participate and must be capable of giving informed consent. Subject information and informed consent forms for adults are provided (documents L1 and L2). No assent or parental consent arrangements described..
- Pregnancy Exclusion
- Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
- Vulnerable Population
- No vulnerable populations selected. Only adults (18 years and older) may participate and must be capable of giving informed consent. Subject information and informed consent forms for adults are provided (documents L1 and L2). No assent or parental consent arrangements described.
Inclusion criteria
- {"criterion_text":"- Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.\n- Scheduled for standard phacoemulsification cataract surgery (group 1 – 3)\n- Scheduled for combined phacoemulsification cataract surgery and MIGS stent (group 4)\n- Ability to cooperate fairly well during the examinations\n- Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol."}
Exclusion criteria
- {"criterion_text":"- Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)\n- Diabetes\n- Mature cataract\n- Active or chronic uveitis with recommendation for steroid treatment\n- Previous trabeculectomy\n- Other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 – 3)\n- Cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Laser flare","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 103
- Consent Approach
- Only adults (18 years and older) may participate and must be capable of giving informed consent. Subject information and informed consent forms for adults are provided (documents L1 and L2). No assent or parental consent procedures described. Languages of consent documents not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 120
Norway
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 01-10-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 120
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Ophthalmology
- Principal Investigator Name
- Olav Kristianslund
- Principal Investigator Email
- olav.kristianslund@gmail.com
- Contact Person Name
- Olav Kristianslund
- Contact Person Email
- olav.kristianslund@gmail.com
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- NEVANAC 3 mg/ml eye drops, suspension
- Active Substance
- NEPAFENAC
- Modality
- Small molecule
- Routes Of Administration
- OPHTHALMIC
- Route
- OPHTHALMIC
- Authorisation Status
- Authorised (marketing authorisation EU/1/07/433/002)
- Frequency
- Max daily: 1 drop
- Maximum Dose
- Max daily: 1 drop; Max total: 21 drops
- Investigational Product Name
- Spersadex 1 mg/ml øyedråper, oppløsning
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- OPHTHALMIC
- Route
- OPHTHALMIC
- Authorisation Status
- Authorised (marketing authorisation 5830, Norway)
- Frequency
- Max daily: 5 drops
- Maximum Dose
- Max daily: 5 drops; Max total: 35 drops
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