Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients

NCT ID: NCT02278614

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-11-30

Brief Summary

The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

Detailed Description

Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

T2347

T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops

Group Type: EXPERIMENTAL

T2347

Intervention Type: DRUG

T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.

Xalacom

Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops

Group Type: ACTIVE_COMPARATOR

Xalacom

Intervention Type: DRUG

Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Interventions

T2347

T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.

Intervention Type: DRUG

Xalacom

Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Intervention Type: DRUG

Other Intervention Names

Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops; Latanoprost 0.005% + Timolol 0.5% preserved eye drops

Eligibility Criteria

Inclusion Criteria

• Signed and dated informed consent,
• Male or female aged > 18 years old,
• Both eyes with open angle glaucoma or ocular hypertension already treated and controlled by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops) since at least 2 months.
• IOP ≤ 18 mmHg in both eyes
• History of IOP insufficiently controlled with first-line monotherapy based on the investigator judgement (e.g. non reaching the target IOP)
• History of an add-on IOP reduction with Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops) in comparison with first-line treatment
• Corneal thickness ≥ 500 μm and ≤ 600 μm in both eyes.

Exclusion Criteria

• Fundoscopy, VF not performed or not available within the 6 months before inclusion visit.
• Significant worsening according to the two last VF (minimum 6 months between these 2 VF)
• Advanced stage of glaucoma:
• Best far corrected visual acuity ≤ 1/10.
• History of trauma, infection, clinically significant inflammation within the 3 months before inclusion visit.
• Ongoing or known history of ocular seasonal and perennial allergy (SAC, PAC) and/or uveitis and/or viral infection.
• Presence of at least one severe objective sign among the following:

• Hyperaemia (Grade 5)
• Superficial punctate keratitis (Grade 3)
• Blepharitis (Grade 3)
• Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).
• Corneal ulceration.
• Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
• History of corneal refractive surgery.
• Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.

• Non-controlled diabetic patient.
• Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
• Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, cardiogenic shock.
• Heart rate <50 bpm, systolic arterial blood pressure≤ 90 mm Hg
• Known or suspected hypersensitivity to one of the components of the study product.
• Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.

• Pregnancy, lactation.
• Childbearing potential woman who is not using a reliable method of contraception

• Inability of patient to understand the study procedures and thus inability to give informed consent.
• Non-compliant patient
• Participation in another clinical study with investigational drug within the last 3 months.
• Already included once in this study.
• Patients being institutionalised because of legal or regulatory order, inmates of psychiatric wards, prison or state institutions, and employees of the study sites or of the Sponsor's company.
• Ward of court.
• Patient not covered by government health care scheme in the country (if applicable).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Thea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg Stalmans, Professor

Role: PRINCIPAL_INVESTIGATOR

Head of the Glaucoma Clinic

Locations

Laboratoires Thea

Clermont-Ferrand, , France

Countries

France

Other Identifiers

LT2347-PIII-12/13

Identifier Type: -

Identifier Source: org_study_id