Ocular Hypertension Clinical Trial
Official title:
A Multicentric, Prospective, Crossover, Double Blind Clinical Study to Evaluate the Non-inferiority of PRO-067 an Ophthlamic Solution Manufactured by Laboratorios Sophia S.A.de C.V., Previous Treatment With GAAP Ofteno ®, in Subjects With Primary Open-angle Glaucoma (POAG) or Ocular Hypertension (OHT): COMPLIANCE Study
Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by
Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive
therapy in subjects with primary open angle glaucoma or ocular hypertension.
Study design: a multicentric, prospective, crossover (2x2), double blind clinical study.
Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.
Patients in the period 1: In the first sequence 60 patients will be assigned to receive the
ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days
and the second sequence 60 patients will be assigned to receive the ophthalmic solution:
PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in
the period 2: the pharmacological intervention change to the opposite therapy for 30 days.
The American Academy of Ophthalmology Glaucoma Panel The primary open angle glaucoma (POAG)
is a progressive, chronic optic neuropathy in adults in which intraocular pressure (IOP) and
other currently unknown factors contribute to damage and in which, in the absence of other
identifiable causes, there is a characteristic acquired atrophy of the optic nerve and loss
of retinal ganglion cells and their axons. This condition is associated with an anterior
chamber angle that is open by gonioscopic appearance.
This is a multicentric, crossover, double blind and prospective clinical study. The
investigators will include patients with confirmed diagnosis of primary open-angle glaucoma
or ocular hypertension, with target intraocular pressure (TIOP) within a range at which a
patient is likely to remain stable or at which worsening of glaucoma will be slow enough that
the risk of additional intervention is not justified.
Patients will be randomly divided into 2 groups, one of them treated with a known formulation
of Latanoprost 0.005% (GAAP Ofteno®, Laboratorios Sophia, Mexico) and the other one treated
with PRO-067 ophthalmic solution. Patients will receive 1 drop per day (QD) into the lower
conjunctival sac of either formulations and were examined at days: 1, 15, 30, 45 ad 60 after
initiation of treatment. A phone call security at day 75 will be performed.
Primary efficacy outcome: To evaluate the efficacy of PRO-067 versus GAAP Ofteno ® instilled
onto the ocular surface in subjects with primary open angle glaucoma (POAG) or ocular
hypertension (HTO), to control and maintenance of the target intraocular pressure (TIOP).
;
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 |
NCT02792803 -
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
|
Phase 4 | |
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 | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Completed |
NCT02993445 -
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
|
N/A | |
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 |
NCT02338362 -
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled 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 |
NCT01995136 -
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
|
Phase 4 | |
Completed |
NCT02003547 -
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
|
Phase 1 | |
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 |
NCT01489670 -
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
|
N/A | |
Completed |
NCT01426867 -
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
|
Phase 2 | |
Completed |
NCT01415401 -
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
|
Phase 4 |