Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients
- Conditions
- Ocular hypertension and glaucomaEar, Nose and Throat
- Registration Number
- ISRCTN17779071
- Lead Sponsor
- aboratoires Thea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 688
1. Informed consent signed and dated. Obtained at the latest at the Screening visit (Visit #1) and prior to the initiation of any study-specific procedures
At Screening visit (Visit#1) (Day -35 to Day-28):
2. Patient aged 18 years old and over
3. Both eyes with a central corneal thickness =500 µm and =600 µm
4. Both eyes with diagnosed ocular hypertension or open-angle glaucoma (primary open-angle, pseudo-exfoliative or pigmentary glaucoma) treated and controlled for at least 6 months by any prostaglandin monotherapy. Patients with one eye with ocular hypertension and the other eye with open-angle glaucoma are eligible.
5. Both eyes with IOP =18 mmHg
At Randomization visit (Visit #2) (Day 1) at 8:00 am:
6. Both eyes with 22 mmHg = IOP <34 mmHg and with asymmetry between eyes =4 mmHg
7. Patient has respected the washout period of at least 28 days
1.1. History of narrow angle and/or angle closure glaucoma
1.2. Functionally significant visual field loss or progressive visual field loss during the last year and/or structural glaucoma progression during the last year detected on the OCT device routinely used by the clinical site
1.3. Advanced stage of glaucoma, defined by at least one of the following criteria:
1.3.1. Severe central visual field loss (i.e., sensitivity loss 10 dB or more in at least 2 of the 4 visual field test points closest to the point of fixation)
1.3.2. Severe visual field loss: MD <-12 dB
1.3.3. Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement
1.3.4. Cup to disk ratio >0.8 (horizontal or vertical measurement)
1.4. History of non-responder to bimatoprost therapy
Ophthalmic exclusion criteria in at least one eye at screening and randomization visits
1.5. Far Best Corrected Visual Acuity = + 0.7 Log Mar (e.g., = 0.2 in decimal value or = 20/100 Snellen equivalent or = 50 ETDRS letters)
1.6. History of trauma, infection, clinically significant inflammation within the previous 3 months
1.7. Ongoing or known history of uveitis and/or viral infection
1.8. Ongoing ocular allergy
1.9. Clinically significant or progressive retinal disease (e.g., para/central retinal degeneration, diabetic retinopathy, retinal detachment)
1.10. Presence of at least one severe objective sign among the following:
1.10.1. Conjunctival hyperemia: Score 5 on the McMonnies scale
1.10.2. Corneal fluorescein staining (CFS) Grade 4 or 5 on the modified Oxford grading scheme
1.10.3. Severe blepharitis: Grade 3 using a 0-3 scale
1.11. Corneal ulceration
1.12. Any abnormality preventing accurate assessment e.g., reliable applanation tonometry measurement, visual field assessment, fundus examination
Systemic/non-ophthalmic exclusion criteria at screening and randomization visits
2.1. Documented uncontrolled diabetic patient
2.2. Known or suspected hypersensitivity to one of the components of the IMP (T4032 or Lumigan®) or diagnostic agents used during the study (e.g., topical anaesthetic, fluorescein, lissamine green)
2.3. History of or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigator’s judgment
Specific exclusion criteria regarding childbearing potential women
3.1. Pregnancy or breast-feeding
3.2. Childbearing potential woman neither surgically sterilized nor using an adequate contraception, as oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch
Exclusion criteria related to general conditions at screening and randomization visits
4.1. Alcohol addiction and/or heavy smoker, according to the investigator’s judgement
4.2. Inability of patient to understand the study procedures or to give informed consent
4.3. Non-compliant patient (e.g., non-compliance to the IMP, not willing to attend a visit or complete a self-questionnaire, way of life interfering with compliance)
4.4. Participation in this study at the same time as another clinical study
4.5. Participation in this study within the 4 weeks after the end of a previous clinical study (or within 5 half-lives of the previously tested product if longer than 4 weeks)
4.6. Patients previously randomized in this study
4.7. Patient being institutionalized because of legal or regulatory order, inmate of psychiatric wards, pris
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraocular pressure (IOP) in the study eye measured using tonometry at nine time-points over a 3 month-study period at 8:00 and 10:00 am and 4:00 pm at Week 2, 6, and Week 12
- Secondary Outcome Measures
Name Time Method