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

NCT02278614 | Completed Phase 3 Results

• 1 other identifier: LT2347-PIII-12/13
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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).

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (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

  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

Study Arms (2)

T2347

EXPERIMENTAL

T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops

Drug: T2347

Xalacom

ACTIVE COMPARATOR

Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops

Drug: Xalacom

Interventions

T2347 DRUG

T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.

Also known as: Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops

T2347

Xalacom DRUG

Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Also known as: Latanoprost 0.005% + Timolol 0.5% preserved eye drops

Xalacom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Non-controlled diabetic patient.
• Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Laboratoires Thea

Clermont-Ferrand, 63017, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost; Timolol; Xalacom

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Director of Medical Operations
• Organization: Laboratoires Théa

J.AUGER@laboratoires-thea.fr

04 73 98 50 89

Study Officials

• Ingeborg Stalmans, Professor

  Head of the Glaucoma Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 30, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 28, 2017
• Results First Posted: January 23, 2017

Record last verified: 2017-03

Locations

FR (1)