Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.

Phase 1

• Conditions: glaucoma, ocular hypertension; MedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-000846-23-IT
• Lead Sponsor: ABORATOIRES THEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 434

Inclusion Criteria

At Screening Visit (D-42):
-Informed consent signed and dated.
-Patient aged =18 years old.
-Both eyes with 500 µm = central corneal thickness = 600 µm.
-Both eyes with diagnosed open-angle glaucoma or ocular hypertension, initially treated and controlled (including IOP = 18 mmHg) for at least 6 months by any prostaglandin monotherapy.
-Both eyes with IOP = 18 mmHg.

At Randomisation Visit (D1) at 8:00:
-Both eyes with 22 mmHg = IOP < 34 mmHg and 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 161
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 273

Exclusion Criteria

Ophthalmic Exclusion Criteria in AT LEAST ONE EYE:
2.1.1 Fundus examination not performed or not available within 12 months.
2.1.2 Visual field not performed or not available within 12 months.
2.1.3 Significant worsening according to the two last visual fields (at least 6 months between the two visual fields).
2.1.4 Advance stage of glaucoma, defined by at least one of the following criteria:
2.1.4.1 Absolute defect in the ten degrees central point of the visual field.
2.1.4.2 Severe visual field loss: MD < -18 dB.
2.1.4.3 Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement.
2.1.5 History of non-responder to bimatoprost therapy.
2.1.6 Far Best Corrected Visual Acuity = + 0.7 Log Mar (e.g., = 0.2 in decimal value or = 20/100 Snellen equivalent or = 50 ETDRS letters).
2.1.7 History of trauma, infection, clinically significant inflammation within the 3 previous months.
2.1.8 Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.
2.1.9 Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment).
2.1.10 Presence of at least one severe objective sign among the following:
2.1.10.1 Conjunctival hyperaemia (Grade 5 / McMonnies scale).
2.1.10.2 Superficial punctate keratitis (Grade 4/5 / Oxford scale).
-2.1.10.3 Blepharitis (Grade 3 / 0-3 scale).
2.1.11 Severe dry eye as assessed by the investigator.
2.1.12 Corneal ulceration.
2.1.13 Any palpebral abnormality incompatible with a good
examination.
2.1.14 Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.

Regarding Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions and Exclusion Criteria Related to Previous and Concomitant Treatments (Medications/Non-Medicinal Therapies/Procedures) please refer to the study protocol in page 30.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of T4032 unpreserved eye drops compared to Lumigan® 0.01% in terms of efficacy. ;Secondary Objective: To evaluate the safety and efficacy of T4032 versus Lumigan® 0.01%.;Primary end point(s): The primary efficacy endpoint is the change in the IOP in the worse eye.;Timepoint(s) of evaluation of this end point: From baseline (day 1) to Week 12 at the three time points (8:00, 10:00, 16:00).