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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02278614
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : January 23, 2017
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Laboratoires Thea

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).

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: T2347 Drug: Xalacom Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.
Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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 Name: 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 Name: Latanoprost 0.005% + Timolol 0.5% preserved eye drops

Primary Outcome Measures :
  1. 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 [ Time Frame: Day 84 ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02278614

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Laboratoires Thea
Clermont ferrand, France, 63017
Sponsors and Collaborators
Laboratoires Thea
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Principal Investigator: Ingeborg Stalmans, Professor Head of the Glaucoma Clinic

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Responsible Party: Laboratoires Thea Identifier: NCT02278614    
Other Study ID Numbers: LT2347-PIII-12/13
First Posted: October 30, 2014    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: April 28, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents