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

Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.

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).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: T2347; Drug: Xalacom

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont ferrand, France, 63017
    • Laboratoires Thea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• Ophthalmic exclusion criteria (in either eye)
• 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.

Systemic/non ophthalmic exclusion criteria

• 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.

Specific exclusion criteria for women

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

Exclusion criteria related to general conditions

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T2347; T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops	Drug: T2347; T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.; Other Names: Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
Active Comparator: Xalacom; Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops	Drug: Xalacom; Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.; Other Names: Latanoprost 0.005% + Timolol 0.5% preserved eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye	the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye. Two relevant time points are considered for this primary criteria: D0 and Day 84.	Day 84

Collaborators and Investigators

• Sponsor: Laboratoires Thea
• Investigators: Principal Investigator: Ingeborg Stalmans, Professor, Head of the Glaucoma Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Timolol; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: LT2347-PIII-12/13