ocular hypertension open-angle glaucoma
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subjects 18 years of age or older, of any race, diagnosed with either open-angle glaucoma (including pseudo exfoliation or pigment dispersion glaucoma) or ocular hypertension 2. Subjects currently on treatment with Travoprost 0.004% / Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening and that in the opinion of the Investigator may benefit from further IOP lowering 3. Qualifying mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) * 19 and * 28 mmHg at 9:00 while on a Travoprost 0.004% / Timolol 0.5% solution) 4. Must be able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee 5. Willing and able to attend all study visits
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential (WOCBP), defined as all women who are not postmenopausal for at least 1 year or less than 6 weeks since sterilization, are excluded from participation if: a. they are currently pregnant, or // b. have a positive result on the urine pregnancy test at Screening, or // c. intend to become pregnant during the study period, or // d. are breast-feeding, or // e. are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. All women of childbearing potential are required to use adequate birth control methods which are summarized as follows: a. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. // b. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before Baseline. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. // c. Male sterilization (at least 6 months prior to Baseline). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject. // d. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. // e. Placement of an intrauterine device (IUD) or intrauterine system (IUS).;2. Subjects with any form of glaucoma other than open-angle glaucoma or ocular hypertension. 3. Subjects with central cornea thickness (CCT) greater than 620 *m as measured by pachymetry in either eye. 4. Subjects with Schaffer angle Grade < 2 in either eye, as measured by gonioscopy (extreme narrow angle with complete or partial closure). 5. Subjects with cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye. 6. Subjects with severe central visual field loss in either eye or field loss threatening fixation in either eye. 7. Subjects with chronic, recurrent or severe inflammatory eye disease (eg, scleritis, uveitis, herpes keratitis) in either eye. 8. Subjects with ocular trauma in either eye within the past 6 months prior to the Screening visit. 9. Subjects with ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit. 10. Subjects with clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. 11. Subjects with best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye. 12. Subjects with other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication. 13. Subjects with intraocular surgery in either eye within the past 6 months prior to the Screening visit. 14. Subjects with ocular laser surgery in either eye within the past 3 months prior to the Screening visit. 15. Subjects with any abnormality preventing reliable applanation tonometry in either eye. 16. Any other conditions including severe illness which would make t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in diurnal IOP (mean of changes at 09:00 and11:00 time points) at Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy: * Diurnal IOP at Week 6. * Percentage change from baseline in diurnal IOP at Week 6. * IOP change from baseline at Week 6 at 11:00 hrs. * Percentage change from baseline in IOP at Week 6 at 11:00 hrs. IOP change from baseline at Week 6 at 09:00 hrs. * Percentage change from baseline in IOP at Week 6 at 09:00 hrs. Exploratory Efficacy: * Difference between treatments in IOP at Week 6 for each time point. * Percentage of subjects achieving diurnal IOP targets (* 12,13,14...,25) at Week 6. * Difference between treatments in Ocular perfusion pressure at week 6 (Diurnal and individual time points). * Mean diurnal IOP, change in diurnal IOP, and percentage change in diurnal IOP at week 6 within subsets of : a. Baseline IOP: 19-24 mmHg, >24-28 mmHg // b. Age category: 65; sex; race (Caucasian, Black, Asian, Hispanic, Other), region (EMEA, Asia, LACAR). | — |
Countries
Argentina, Australia, Belgium, Chile, Colombia, France, Germany, Greece, Italy, Korea (the Democratic Peoples Republic of), Malaysia, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed