Ocular Hypertension Clinical Trial
— SYLTAGOfficial title:
A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
Verified date | December 2020 |
Source | Sylentis, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
Status | Completed |
Enrollment | 184 |
Est. completion date | January 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients older than 18 years of either sex - Good or fair general health as assessed by the investigator. - Signed informed consent prior to any clinical trial-related procedures - Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) - Post-washout mean IOP above target range - BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200) - Stable visual field - Central corneal thickness 480-620 µm - Shaffer gonioscopic grade of = 3 (in at least 3 quadrants) in both eyes Exclusion Criteria: - Pregnant or breastfeeding females - Females of childbearing potential not willing to use a medically acceptable contraceptive method - Clinically significant systemic disease - Changes of systemic medication that could have a substantial effect on IOP - Known hypersensitivity to any component of the formulations - Unable to comply with the clinical trial requirements - Clinically significant abnormalities in laboratory tests - Severe visual field defect - Any secondary glaucoma - Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. - IOP = 35 mm Hg in any eye - Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery - Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to Baseline - Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis - Clinically significant ocular disease |
Country | Name | City | State |
---|---|---|---|
Estonia | East Tallin Central Hospital | Tallin | |
Estonia | Eye Clinic Dr. Krista Turman | Tallin | |
Estonia | Tartu University Hospital | Tartu | |
Germany | Universitaetsklinikum Freiburg | Freiburg | |
Germany | University Clinic Magdeburg | Magdeburg | |
Germany | Klinikum der Universität München | München | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | University Hospital Regensburg | Regensburg | |
Spain | Hospital Clinic | Barcelona | |
Spain | Hospital de Jerez | Jerez de la Frontera | Cádiz |
Spain | Hospital Universitario Clínico San Carlos | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Clinica Universidad Navarra | Pamplona | Navarra |
Spain | Complejo Hospitalario de Pontevedra | Pontevedra | |
Spain | Hospital de Torrevieja | Torrevieja | Alicante |
Spain | Instituto de Oftalmobiología Aplicada | Valladolid | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
United States | Sall Research Medical Center | Artesia | California |
United States | Taustin Eye Center | Louisville | Kentucky |
United States | Eye Care Centers Management, Inc (Clayton Eye Center) | Morrow | Georgia |
United States | North Bay Eye Associates | Petaluma | California |
Lead Sponsor | Collaborator |
---|---|
Sylentis, S.A. |
United States, Estonia, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm | Baseline and Day 28 | ||
Secondary | Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm | Baseline and Day 14 | ||
Secondary | Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm | The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life. | Baseline and Day 29 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03284853 -
Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
|
Phase 3 | |
Completed |
NCT01157364 -
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06441643 -
Next Generation Rocklatan
|
Phase 2 | |
Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
Recruiting |
NCT02792803 -
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
|
Phase 4 | |
Terminated |
NCT02801617 -
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
|
Phase 3 | |
Completed |
NCT02558374 -
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
|
Phase 3 | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 | |
Completed |
NCT02338362 -
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
|
Phase 4 | |
Completed |
NCT02993445 -
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
|
N/A | |
Completed |
NCT01936389 -
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
|
Phase 2 | |
Completed |
NCT02003547 -
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01995136 -
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
|
Phase 4 | |
Completed |
NCT01693315 -
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
|
Phase 2 | |
Completed |
NCT01664039 -
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
|
Phase 4 | |
Active, not recruiting |
NCT01430923 -
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost
|
N/A | |
Completed |
NCT01410188 -
Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
|
Phase 1/Phase 2 | |
Completed |
NCT01489670 -
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
|
N/A |