Clinical Trials Logo

Clinical Trial Summary

A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment.


Clinical Trial Description

Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomized, active-controlled trial Study duration: - 5 days to 5-week washout period - 15 months for the first 130 patients - 12 weeks for the next 250 patients Patients will attend 6 visits following the wash-out phase (up to 5 weeks): - Period 1 (3-month investigator-masked treatment period, DE-130A vs Xalatan®): Randomization/Baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days) - Period 2 (12-month follow-up from Week 12, open-label DE-130A treatment for the first 130 patients who complete their week 12 visit and agree to participate in the open-label period of the study): Month 6 (± 7days), Month 9 (±7 days) and Month 15 (± 1 week) visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04133311
Study type Interventional
Source Santen SAS
Contact
Status Completed
Phase Phase 3
Start date April 10, 2019
Completion date October 26, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04067973 - Impact of Prematurity on the Optic Nerve
Completed NCT04828057 - Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting
Not yet recruiting NCT06375343 - Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® Phase 1
Completed NCT00346450 - Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation Phase 3
Completed NCT04351100 - Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
Completed NCT03659955 - Autologous Blood Treatment for Ocular Surface Disease N/A
Completed NCT04536129 - Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure N/A
Completed NCT01254370 - Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease Phase 2
Completed NCT00554411 - Assessing Ocular Surface Changes After Changing Glaucoma Medications N/A
Completed NCT03769454 - A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers Phase 1
Recruiting NCT06256770 - Evaluation of the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses for the Correction of Ametropia
Completed NCT04673604 - From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy N/A
Not yet recruiting NCT06370585 - Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF Phase 1
Withdrawn NCT04735510 - Novel Use of Restasis and PROSE Devices Phase 3
Suspended NCT00348114 - Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency Phase 2
Recruiting NCT04010422 - Ocular Function in Autism Spectrum Disorder
Completed NCT05528016 - Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty N/A
Completed NCT04452279 - Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification N/A
Completed NCT04535388 - LK Scleral Lens for Patients With Intractable Ocular Surface Diseases N/A
Recruiting NCT06298890 - The Pattern of Dry Eye Disease After Cataract Surgery