Clinical trial • Phase IV • Ophthalmology

BRIMONIDINE for Open-angle glaucoma | Pseudoexfoliation glaucoma

Phase IV trial of BRIMONIDINE for Open-angle glaucoma | Pseudoexfoliation glaucoma.

Overview

Trial Therapeutic Area: Ophthalmology
Trial Disease: Open-angle glaucoma | Pseudoexfoliation glaucoma
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 06-05-2024
First CTIS Authorization Date: 16-05-2024

Trial design

Randomised, conventional stepwise treatment (standard clinical treatment) versus intensive non-invasive glaucoma treatment (mono drop therapy and combo drop therapy + third medication + ltp 360°); specific drug names/doses/schedules not specified in the record.-controlled Phase IV trial across 1 site in Sweden.

Randomised: Yes
Comparator: Conventional stepwise treatment (standard clinical treatment) versus intensive non-invasive glaucoma treatment (mono drop therapy and combo drop therapy + third medication + LTP 360°); specific drug names/doses/schedules not specified in the record.
Target Sample Size: 240
Trial Duration For Participant: 3650

Eligibility

Recruits 240 No vulnerable population selected; no specific consent or assent handling described in the record..

Pregnancy Exclusion: Pregnant or breast feeding women or women in childbearing potential not using acceptable contraceptive method.
Vulnerable Population: No vulnerable population selected; no specific consent or assent handling described in the record.

Inclusion criteria

{"criterion_text":"- Newly diagnosed open-angle glaucoma (incl. normal pressure glaucoma) or PEX glaucoma in one or both eyes (both eyes can be included as study eyes if they fulfill the criteria of inclusion/exclusion)."}
{"criterion_text":"- VFI (Visual Field Index)≥65%, applicable for both eyes even if only one eye will be included."}
{"criterion_text":"- Patient should be previously untreated with intraocular pressure lowering medication."}
{"criterion_text":"- Age: 40-78 years at time of inclusion."}

Exclusion criteria

{"criterion_text":"- Pregnant or breast feeding women or women in childbearing potential not using acceptable contraceptive method."}
{"criterion_text":"- Patients with contraindications to the glaucoma medicine to be given."}
{"criterion_text":"- If there is any obstacle for performing the LTP."}
{"criterion_text":"- Disease or condition that probably prohibits long-term follow-up."}
{"criterion_text":"- Intraocular surgery except uncomplicated cataract operation."}
{"criterion_text":"- Diabetes with proliferative retionopathy or serious non-proliferative retionopathy [(intra-retinal bleedings, pronounced intra-retinal microvasculation, \"definite venous beading\" macular edema with hard exudates that reach fovea according to International Clinical Diabetic Retionopathy and Macular Edema Disease Severity scales (Wilkinson et al 2003)]."}
{"criterion_text":"- Neurological and other non-glaucoma conditions, except cataract, that can affect the vision."}

Endpoints

Primary endpoints

{"endpoint_text":"- Rate of progression, the aim of the study is to compare and follow-up the patients on traditional clinical treatment with those receiving more intensive treatment, and measure the rate of progression as long as possible.","definition_or_measurement_approach":"Perimetric rate of progression (compare perimetric progression between treatment strategies); perimetry (Standard Automated Perimetry with Humphrey Field Analyser) and longitudinal follow-up to measure rate of progression."}

Secondary endpoints

{"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Quality of life measured for randomised patients at one month and after 3, 5, 8 and 10 years; QoL in relation to treatment alternative and rate of progression."}
{"endpoint_text":"- Compliance and adherence","definition_or_measurement_approach":"Monitor the effect of adherence on rate of progression (adherence/compliance monitoring described as a secondary objective)."}

Recruitment

Planned Sample Size: 240
Recruitment Window Months: 170

Geography

Total Number Of Sites: 1
Total Number Of Participants: 240

Sweden

Earliest CTIS Part Ii Submission Date: 04-12-2023
Latest Decision Or Authorization Date: 16-05-2024
Processing Time Days: 164
Number Of Sites: 1
Number Of Participants: 240

Sites

Site Name: Region Vaesterbotten
Department Name: Ögonkliniken
Principal Investigator Name: Gauti Jóhannesson
Principal Investigator Email: gauti.johannesson@umu.se
Contact Person Name: Gauti Jóhannesson
Contact Person Email: gauti.johannesson@umu.se

Sponsor

Primary sponsor

Full Name: Region Vaesterbotten
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Sweden

Investigational products

Investigational Product Name: BRIMONIDINE
Active Substance: BRIMONIDINE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 2 Gtt drop(s) per day
Maximum Dose: 7300 Gtt drop(s)

Investigational Product Name: PILOCARPINE NITRATE
Active Substance: PILOCARPINE NITRATE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 3 Gtt drop(s) per day
Maximum Dose: 10950 Gtt drop(s)

Investigational Product Name: BRINZOLAMIDE
Active Substance: BRINZOLAMIDE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 3 Gtt drop(s) per day
Maximum Dose: 10950 Gtt drop(s)

Investigational Product Name: TIMOLOL MALEATE
Active Substance: TIMOLOL MALEATE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 2 Gtt drop(s) per day
Maximum Dose: 7300 Gtt drop(s)

Investigational Product Name: LATANOPROST
Active Substance: LATANOPROST
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 1 Gtt drop(s) per day
Maximum Dose: 3650 Gtt drop(s)

Investigational Product Name: BRINZOLAMIDE, BRIMONIDINE TARTRATE
Active Substance: BRINZOLAMIDE, BRIMONIDINE TARTRATE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 2 Gtt drop(s) per day
Maximum Dose: 7300 Gtt drop(s)

Investigational Product Name: TIMOLOL, TRAVOPROST
Active Substance: TIMOLOL, TRAVOPROST
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 1 Gtt drop(s) per day
Maximum Dose: 3650 Gtt drop(s)

Investigational Product Name: BETAXOLOL
Active Substance: BETAXOLOL
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 2 Gtt drop(s) per day
Maximum Dose: 7300 Gtt drop(s)

Investigational Product Name: BIMATOPROST
Active Substance: BIMATOPROST
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 1 Gtt drop(s) per day
Maximum Dose: 3650 Gtt drop(s)

Investigational Product Name: DORZOLAMIDE HYDROCHLORIDE
Active Substance: DORZOLAMIDE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 3 Gtt drop(s) per day
Maximum Dose: 10950 Gtt drop(s)

Investigational Product Name: DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Active Substance: DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 2 Gtt drop(s) per day
Maximum Dose: 7300 Gtt drop(s)

Investigational Product Name: TAFLUPROST
Active Substance: TAFLUPROST
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Frequency: Up to 1 Gtt drop(s) per day
Maximum Dose: 3650 Gtt drop(s)

Combination Treatment: Yes

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