E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cataract surgery, and the medical treatment is anti-inflammatory eye drops to treat (and prevent) intraocular inflammation and development og cystoid macular edema. |
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E.1.1.1 | Medical condition in easily understood language |
In this trial, we will study anti-inflammatory eye drops used in relation to cataract surgery - to remove the lens inside the eye. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Compare postoperative intraocular inflammation between different medication regimens for cataract surgery |
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E.2.2 | Secondary objectives of the trial |
• Compare central macular thickness and the risk of cystoid macular edema • Compare visual outcome • Compare intraocular pressure • Compare glare • Compare patient-reported outcome measures ---between the medication groups |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study if all of the following criteria apply: • Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit. • Scheduled for standard phacoemulsification cataract surgery (group 1 – 3) • Scheduled for combined phacoemulsification cataract surgery and MIGS stent (group 4) • Ability to cooperate fairly well during the examinations • 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.
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E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply: • Contraindications for use of any medication (e.g. allergy, pregnancy, breastfeeding) o Pregnancy is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5 • Diabetes • Mature cataract • Active or chronic uveitis with recommendation for steroid treatment • Previous trabeculectomy • Other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 – 3) • Cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation) Patients with complications or other complicating factors during surgery that causes the surgeon to demand both NSAIDs and steroid treatment will be excluded from the main analysis. These patients will be followed postoperatively as part of the study and included in additional analyses (for example as part of an intention to treat analysis).
For patients scheduled for cataract surgery in both eyes, only the first operated eye will be included, however, both eyes will be examined.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Preoperatively, 1 week, 6 weeks, 6 months after surgery |
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E.5.2 | Secondary end point(s) |
• Central macular thickness and macular cysts on optical coherence tomography • Corrected distance visual acuity • Intraocular pressure (applanation) • Straylight value • Comtol-scheme for ocular medication |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Preoperatively, 1 week, 6 weeks, 6 months after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |