Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
T2347
Xalacom
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
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:
- 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).
Sites / Locations
- Laboratoires Thea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2347
Xalacom
Arm Description
T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02278614
Brief Title
Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2347
Arm Type
Experimental
Arm Description
T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
Arm Title
Xalacom
Arm Type
Active Comparator
Arm Description
Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Intervention Type
Drug
Intervention Name(s)
T2347
Other Intervention Name(s)
Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
Intervention Description
T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.
Intervention Type
Drug
Intervention Name(s)
Xalacom
Other Intervention Name(s)
Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Intervention Description
Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg Stalmans, Professor
Organizational Affiliation
Head of the Glaucoma Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoires Thea
City
Clermont ferrand
ZIP/Postal Code
63017
Country
France
12. IPD Sharing Statement
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Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
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