E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Medically uncontrolled glaucoma that requires filtration surgery. |
Formålet med dette studie er at undersøge hvilken postoperativ antiinflammatorisk behandling, der giver den bedste langsigtede kontrol af øjentrykket hos patienter med grøn stær (glaukom) efter filtrationskirurgi (trabekulektomi). |
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E.1.1.1 | Medical condition in easily understood language |
Eye pressure following glaucoma surgery |
Øjentrykket hos patienter med grøn stær efter filtrationskirurgi. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018326 |
E.1.2 | Term | Glaucoma NOS |
E.1.2 | System Organ Class | 100000004853 |
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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 |
The purpose of this study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids or a combination of the two and to explore the mechanisms behind the pathophysiology of glaucoma. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry. |
Formålet med dette studie er at undersøge hvilken postoperativ antiinflammatorisk behandling efter grøn stær operation, der giver den bedste langsigtede kontrol af øjentrykket hos patienter med grøn stær (glaukom) efter filtrationskirurgi (trabekulektomi).
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
INCLUSION CRITERIA •Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) and ocular hypertension •>50 years •Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months. •Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark •Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study •Informed consent to participation and ability to comply with study procedures
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E.4 | Principal exclusion criteria |
EXCLUSION CRITERIA •Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study •Prior intraocular surgery, except from cataract surgery •Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma •Steroid responders •Pregnancy •Fertile women, i.e. women who are not menopausal and women who breastfeed •Patients who are excluded due to perioperative complications will not provide data for the study. •Patients in systemic treatment with steroid or NSAID
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
•postoperative intraocular pressure at 24 months, •best corrected visual acuity (logMAR) at 12 and 24 months, •changes in visual field at 12 and 24 months, •optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL) by peripapillary optical coherence tomography (OCT) at 12 and 24 months •lens evaluation at, 12- and 24 months by pentacam •bleb morphology at 12 and 24 months •surgical success at 12 and 24 months.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 months: best corrected visual acuity (logMAR), changes in visual field, optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL), lens evaluation, bleb morphology, surgical success
24 months: postoperative intraocular pressure, best corrected visual acuity (logMAR), changes in visual field, optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL), lens evaluation, bleb morphology, surgical success
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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 | No |
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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |