The main objective is to assess the safety and the efficacy, in intra ocular pressure, of Geltim LP ® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to Prostaglandin eye drops. MedDRA version: 9.1 Level: LLT Classification code 10018304 Term: Glaucoma MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension
Conditions
Interventions
Trade Name: Geltim LP ® 1 mg/g (0.1% timolol maleate gel, without preservative) packaged in single-dose containers (unidoses)
Pharmaceutical Form: Eye gel
Trade Name: Xalatan® (latanoprost 0.005% pre
Sponsors
Laboratoires THEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion in this study if all these criteria are respected: -Male or female aged from 18 to 90 years old. -Written informed consent. -Association of the 4 following criteria: 1 – Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day). 2 – IOP = 18 mm Hg in BOTH eyes 3 – With local intolerance signs in at least one eye defined by the association of: 3.1-Presence of at least 2 symptoms with a level of severity = 1 (= mild or moderate or severe) among the following 8 symptoms: irritation / burning, itching, tearing, stinging upon instillation, eye dryness sensation, foreign body sensation, photophobia, blurred vision, and 3.2-Presence of at least 1 objective sign among the following: •Hyperaemia = Grade (3) or (4) or (5) following McMonnies scale •Superficial Punctate Keratitis (SPK) (Grade 1 or 2) •Inter-palpebral conjunctival stainings (Grade 1 or 2) •Folliculo papillary conjunctivitis (Grade 1 or 2) •Blepharitis (Grade 1 or 2) •BUT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ophthalmic non inclusion criteria in either eye Patients fulfilling at the inclusion visit ONE OR MORE of the following non inclusion criteria will not be included in the study: -Presence of at least one severe objective sign among the following: •Hyperaemia (Grade 6) •Superficial Punctate Keratitis (Grade 3) •Inter-palpebral conjunctival stainings (Grade 3) •Folliculo papillary conjunctivitis (Grade 3) •Blepharitis (Grade 3) -Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma) -Absolute defect in the ten degrees central point of the visual field. -Best far corrected visual acuity = 1/10. -Aphakia after cataract surgery with no IOL (Intra-Ocular Lens). -History of traumatism, infection, inflammation within the 3 months before inclusion visit. -Severe on-going ocular allergy. -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). -Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination. -Visual field not performed or not available within the 6 months before inclusion visit. -Risk of visual field worsening as a consequence of participation in the trial according to the investigator’s best judgement. Systemic/non ophthalmic/ non inclusion criteria -Absolute contraindications for timolol maleate: •Hypersensitivity to timolol maleate, to other beta-blockers or to any component of the drug product, •Asthma, chronic obstructive lung disease, history of asthma, bronchial hyperreactivity and severe allergic rhinitis, •Cardiac insufficiency unsatisfactorily controlled by the treatment, •Cardiogenic shock, •Second and third degree atrioventricular blocks in the absence of a pacemaker, •Prinzmetal’s angina, •Sinus disease (including sinoatrial block), •Bradycardia (< 45 to 50 beats per minute), •Raynaud’s disease and peripheral circulatory disturbances, •Untreated pheochromocytoma, •Hypotension •Corneal distrophia -Non-controlled diabetic patient -Known or suspected hypersensitivity to one of the components of the study medication -Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplasic, 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 non-inclusion criteria for female patients -Pregnancy, lactation. -Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, patch). OR -Women not hysterectomised, menopaused or surgically sterilized Non-inclusion criteria related to general conditions -Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent -Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance). -Participation in another clinical study. -Already included once in this study -Ward of court. -Patient not covered by the Social Security scheme Non-inclusion criteria related to previous and concomitant medications / non-product therapies. Patient using any of the following previous and concomitant med
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Ocular tolerance Worst eye = most severe eye defined by the highest intolerance score (sum of the score of 8 symptoms + sum of the score of 6 objective signs). In case both eyes are eligible and have the same total intolerance score at D0, the eye with the highest IOP is considered, and if the IOP is the same for both eyes, the right eye is considered. •Ocular symptoms (irritation/burning, itching, tearing, stinging upon instillation, eye dryness sensation, foreign body sensation, photophobia, blurred vision) •Objective ocular signs (conjunctival hyperaemia, folliculo-papillary conjunctivitis, SPK, blepharitis, interpalpebral conjunctival staining, BUT) Efficacy on the IOP •The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7);Secondary Objective: Other tolerance criteria •Global discomfort assessed by the patient with a Visual Analogue Scale (VAS) •The sum of the score of 8 ocular symptoms and the score of each ocular symptoms •The sum of the score of 6 objective signs and the score of each objective signs •Funduscopy •Global local tolerance assessed by the Investigator. •Global local tolerance assessed by the patient •Number of associated eye drops treatments + evolution of their dose regimen •Other ocular AE reporting •Systemic AE reporting Efficacy on the IOP •Comparison between the 2 study products of the mean basal IOP after a 4 weeks treatment period (28 days ± 3 days) •Global efficacy assessed by the investigator. •Number of withdrawals for therapeutic failure;Primary end point(s): This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP ® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops. | — |
Countries
France
Outcome results
None listed