Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.

Korábbi kezelés

• Currently undergoing treatment with any systemic ocular hypotensive agent (e.g., mannitol, glycerin, isosorbide).
• Patients requiring the use of monoamine oxidase inhibitors (MAOIs), and patients treated with antidepressants affecting noradrenergic transmission (e.g., tricyclic antidepressants and mianserin).
• Patients who use, or have used in the last month, topical ocular steroids in the eye to be included in the study, or steroids via oral, intravenous, intramuscular, dermal, or intralesional routes.
• Have participated in another clinical research study within 30 days prior to signing the informed consent form (ICF).
• Have previously participated in this study.
• Have a history of drug addiction within the last two years prior to signing the ICF.
• Have any type of surgical intervention planned during the study period.

Más betegség

• History of ocular surgery or laser eye procedure in the last 6 months in the eye to be included in the study.
• History of ocular trauma in the last 6 months in the eye to be included in the study.
• History of chronic uveitis in the eye to be included in the study.
• History of intraocular, periocular, retrobulbar, subconjunctival, or subtenon injection in the last 6 months in the eye to be included in the study.
• Known hypersensitivity to the active ingredients used in the study (prostaglandin analogues, β-adrenergic blockers, α2-adrenergic agonists, carbonic anhydrase inhibitors).
• Diseases that contraindicate the use of the active ingredients used in the study (e.g., severe asthma or COPD, 2nd or 3rd degree atrioventricular block not controlled by a pacemaker, sinus bradycardia, manifest heart failure, Chronic Kidney - - Disease with a CrCl < 30 ml/min).

Életkor

• For women of reproductive age, not using a hormonal contraceptive method, intrauterine device, or bilateral tubal ligation.

Egyéb

• Pregnant, breastfeeding, or planning to become pregnant during the clinical study.
• Anterior chamber angle < 2 in the Shaffer Classification or presence of peripheral anterior synechiae in the eye to be included in the study.
• Best Corrected Visual Acuity worse than 20/200 in the eye to be included in the study.
• Severe central visual field loss (sensitivity ≤ 10 dB in ≥ 2 of the 4 central points of the visual field fixation point) in the eye to be included in the study.
• Patients with silicone, or who have had silicone in the anterior or posterior segment of the eye to be included in the study.
• Diagnosis of aphakia in the eye to be included in the study.
• Any corneal abnormality that decreases the reliability of Goldmann tonometry in the eye to be included in the study.
• Be or have an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is part of the research site personnel or the sponsor

• Subjects with primary open-angle glaucoma (according to the Preferred Practice Pattern guidelines of the American Academy of Ophthalmology) or ocular hypertension, not controlled by a prostaglandin analogue or a β-blocker in the eye to be included in the study.
• Previous treatment for at least 30 days prior to the eligibility visit with a prostaglandin analogue or a β-blocker in the eye to be included in the study.
• Intraocular pressure measured by Goldmann tonometry ≥ 19 and ≤ 26 mmHg in the eye to be included in the study.
• Ability to voluntarily provide informed consent.
• Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
• Age ≥ 18 years.