Overview

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

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratoires Thea
Treatments:
Latanoprost
Ophthalmic Solutions
Tetrahydrozoline
Timolol
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:

- 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).