Open Angle GlaucomaPhase 3NCT02278614
Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
A Phase 3 study testing T2347 and Xalacom in people with Open Angle Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- T2347 and Xalacom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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
- Being tested
- T2347, Xalacom
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2347Drug
Also called Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.
XalacomDrug
Also called Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
| Study group | Role | What they receive |
|---|---|---|
| T2347 | Experimental | T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops Receives: Drug: T2347 |
| Xalacom | Active comparator | Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops Receives: Drug: Xalacom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, Professor, Principal investigator, Head of the Glaucoma Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278614
- Sponsor's protocol ID
- LT2347-PIII-12/13
- Status last verified
- Mar 2017
- First submitted
- 15 Oct 2014
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02278614
- Acronym / sponsor ID
- LT2347-PIII-12/13
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 23 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2347 | Experimental | Drug: T2347T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops |
| Xalacom | Active comparator | Drug: XalacomXalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2347Also: Latanoprost 0.005% + Timolol 0.5% unpreserved eye dropsT2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers. | Drug | T2347 |
| XalacomAlso: Latanoprost 0.005% + Timolol 0.5% preserved eye dropsXalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container. | Drug | Xalacom |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg Stalmans, Professor principal investigator
Head of the Glaucoma Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T2347 and Xalacom in people with Open Angle Glaucoma and Ocular Hypertension, run by Laboratoires Thea at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.