Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.

Phase 1

• Conditions: Glaucoma, ocular hypertension; MedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2017-002823-46-HU
• Lead Sponsor: aboratoires THÉA; Research and Development Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

At Screening Visit:
1.1.Informed consent signed and dated
1.2.Patient aged =18 years old
1.3.500 µm = central corneal thickness = 600 µm in both eyes
1.4.Both eyes with diagnosed open angle glaucoma or ocular hypertension:
1.4.1Initially treated and controlled for at least 6 months by dual therapy of prostaglandin and timolol (fixed combination or not)
1.4.1.1.Both eyes with IOP = 18 mmHg
1.4.1.2.History of IOP insufficiently controlled with first-line monotherapy based on the following reasons:
•No sufficient IOP reduction
Or
•Significant IOP reduction but progression of glaucoma (target IOP not reached)
1.4.1.3.Justification of an add-on IOP reduction with a combination of prostaglandin and timolol (fixed or not) 6 months after the switch from monotherapy to dual therapy (bitherapy)
OR
1.4.2Initially treated with first-line monotherapy for at least 6 months, insufficiently controlled and requiring a dual therapy (bitherapy)
At Randomisation Visit (Day 1) at 9h00:
1.5.Both eyes with 22 mmHg = IOP < 36 mmHg with asymmetry between eyes = 3 mmHg

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion Criteria

Ophthalmic Exclusion Criteria in AT LEAST ONE EYE [2.1]
2.1.1Funduscopy not performed or not available within 12 months
2.1.2Visual field not performed or not available within 12 months
2.1.3Advanced stage of glaucoma defined by at least one of the following criteria:
2.1.3.1Absolute defect in the ten degrees central point of the visual field
2.1.3.2Severe visual field loss : MD < -18 dB
2.1.3.3Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement
2.1.4History of non-response to bimatoprost and/or timolol
2.1.5Far Best Corrected Visual Acuity = +0.7 LogMar (e.g., =0.2 in decimal value or =20/100 Snellen equivalent or =50 ETDRS letters)
2.1.6History of trauma, infection, clinically significant inflammation within the 3 previous months
2.1.7Ongoing or known history of ocular allergy and/or uveitis and/or viral infection
2.1.8Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment)
2.1.9Presence of at least one severe objective sign among the following:
2.1.9.1Conjunctival hyperaemia (Grade 5 / McMonnies scale)
2.1.9.2Superficial punctate keratitis (Grade 4-5 / Oxford scale)
2.1.9.3Blepharitis (Grade 3 / 0-3 scale)
2.1.10Severe dry eye as assessed by the investigator
2.1.11Corneal ulceration
2.1.12Palpebral abnormalities incompatible with a good examination
2.1.13Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination

Systemic/Non Ophthalmic Exclusion Criteria [2.2]
2.2.1Uncontrolled diabetic patient
2.2.2History of cardiac disorders (except controlled arterial hypertension)
2.2.3Any ECG abnormalities considered clinically significant and/or contraindicating the prescription of Timolol (Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, or any relevant abnormalities) according to centralised medical review,
2.2.4Heart rate <50 bpm and/or systolic arterial blood pressure =90 mmHg
2.2.5History of bronchopulmonary disorders (e.g. asthma, chronic obstructive pulmonary disease)
2.2.6Known or suspected hypersensitivity to one of the components of the investigational product, run in treatment (sulphonamides) or auxiliary product (fluorescein, oxybuprocaine hydrochloride)
2.2.7History of or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigator judgement

Specific Exclusion Criteria Regarding Childbearing Potential Women[2.3]
2.3.1Pregnancy or breast feeding
2.3.2Childbearing woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch, double-barrier – i.e. condom associated with spermicide) and is not surgically sterilised

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified