Ocular Hypertension Clinical Trial
Official title:
An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma
The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients with primary open angle glaucoma. The study will also aim to prove the tolerability of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.
Since the introduction of Xalatan generic versions of latanoprost have entered the Canadian
marketplace such as Apo-latanoprost (Apotex Inc.), Co-latanoprost (Cobalt Pharmaceuticals
Co.) and Sandoz latanoprost (Sandoz Canada Inc.). The exact formulation of the different
preparations of latanoprost may differ between manufacturers, although the active ingredient
itself is not supposed to vary within a 15% tolerance. In a topical ocular medication in a
multi-dose dispenser, the stability of the drug and its ability to penetrate the cornea into
the eye may affect the efficacy of the drug.
There are no clinical trials to compare the efficacy of generic versions of latanoprost to
Xalatan, nor are there any clinical trials comparing efficacy between the different generic
versions. Empirical evidence based on clinical experience suggests that at least some of the
generic versions of latanoprost may not be as effective as the branded version (Xalatan).
Intraocular pressure is often observed to increase when switching from a branded to generic
version of latanoprost, but the opposite is rarely if ever observed. The purpose of this
study will be to compare the efficacy of Xalatan to two of the most popular generic versions
of latanoprost available in Canada (Apo-latanoprost and Co-latanoprost).
;
| 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 | |
| Completed |
NCT02558374 -
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Terminated |
NCT02801617 -
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02338362 -
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
|
Phase 4 | |
| Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
| Completed |
NCT02993445 -
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
|
N/A | |
| Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
| 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 |
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 |
NCT01664039 -
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
|
Phase 4 | |
| Completed |
NCT01693315 -
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
|
Phase 2 | |
| 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 |
NCT01415401 -
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
|
Phase 4 | |
| Completed |
NCT01489670 -
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
|
N/A |