diclofenac sodium for Primary open-angle glaucoma | Pseudoexfoliation syndrome | Pigment dispersion syndrome | Ocular hypertension

Inclusion criteria

• {"criterion_text":"- Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) and ocular hypertension\n- >50 years\n- Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months.\n- Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark\n- 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\n- Informed consent to participation and ability to comply with study procedures"}

Exclusion criteria

• {"criterion_text":"- Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study\n- Prior intraocular surgery, except from cataract surgery\n- Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma\n- Steroid responders\n- Pregnancy\n- Fertile women, i.e. women who are not menopausal and women who breastfeed\n- Patients who are excluded due to perioperative complications will not provide data for the study.\n- Patients in systemic treatment with steroid or NSAID"}

Primary endpoints

• {"endpoint_text":"- The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.","definition_or_measurement_approach":"Intraocular pressure measured by applanation tonometry at 12 months after surgery."}

Secondary endpoints

• {"endpoint_text":"- Postoperative intraocular pressure at 24 months","definition_or_measurement_approach":"Intraocular pressure (postoperative) measured at 24 months (method not further specified)."}
• {"endpoint_text":"- Best corrected visual acuity (logMAR) at 12 and 24 months","definition_or_measurement_approach":"Best corrected visual acuity reported in logMAR at 12 and 24 months."}
• {"endpoint_text":"- Changes in visual field at 12 and 24 months","definition_or_measurement_approach":"Visual field changes assessed by standard visual field testing at 12 and 24 months (specific test not specified)."}
• {"endpoint_text":"- Optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL) by peripapillary optical coherence tomography (OCT) at 12 and 24 months","definition_or_measurement_approach":"Retinal nerve fiber layer (RNFL) thickness measured by peripapillary optical coherence tomography (OCT) at 12 and 24 months."}
• {"endpoint_text":"- Lens evaluation at, 12- and 24 months by pentacam","definition_or_measurement_approach":"Lens evaluated using Pentacam at 12 and 24 months."}
• {"endpoint_text":"- Bleb morphology at 12 and 24 months","definition_or_measurement_approach":"Bleb morphology assessed at 12 and 24 months (method not specified)."}
• {"endpoint_text":"- Surgical success at 12 and 24 months","definition_or_measurement_approach":"Surgical success assessed at 12 and 24 months (specific success criteria not provided in summary)."}

Denmark

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

25

Number Of Sites

1

Number Of Participants

72

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties codes: 1; 15: Danish GCP unit","organisation_type":"Hospital/Clinic/Other health care facility"}