Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension (COMPLIANCE)
Primary Open Angle Glaucoma, Ocular Hypertension
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Latanoprost, Glaucoma, Ocular hypertension, Crossover study
Eligibility Criteria
Inclusion Criteria:
- Female or male
- Age: ≥18 years old
- Patients with primary open angle glaucoma with mild to moderate damage or ocular hypertension that were sufficiently controlled with GAAP Ofteno® (latanoprost 0.005%) within the last 60 days
- Signed Informed Consent Form
Exclusion Criteria:
- Subjects with unique eye
- Subjects with visual acuity < 20/200
- Another kind of glaucoma disease different to primary open angle glaucoma
- corneal disturbances with impossibility to measure the intraocular pressure
- retinal alterations without control or progressive retinal disease with high risk to lost vision
Sites / Locations
- Contract Research Organization
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sequence 1 (PRO-067)
Sequence 2 (GAAP Ofteno®)
study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours
study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours