Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients.

SOPH122-0420/IV

Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days

2021-10-19

2023-11-23

2023-11-23

Terminated

Early phase I

28

Inclusion Criteria: * Patients with diagnosed primary open angle glaucoma or ocular hypertension, not using a prostaglandin analogue or a β-blocker in the eye to be included in this study. * No treatment with any prostaglandin analogues or a β-blockers within the 30 days previous to eligibility visit, in the eye to be included in this study. * IOP measured with Goldmann tonometer ≥ 19 and ≤ 26 mmHg, in the eye to be included in this study. * Being capable of voluntarily grant a signed informed consent. * Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures. * Age ≥18 years old. Exclusion Criteria: * Pregnancy, breastfeeding or planning to become pregnant during the time of the study * In the case of women of childbearing age, not counting with a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction. * Anterior chamber angle \< 2 in Shaffer's scale, or presence of peripheral anterior synechia, in the eye to be included in the study. * Being currently under treatment with any systemic ocular hypotensive drug (mannitol, glycerin, isosorbide, etc). * BCVA worse than 20/200, in the eye to be included in the study. * Serious loss of central visual field (sensibility ≤ 10 dB in ≥ 2 of the central sites), in the eye to be included in the study. * Having a previous history of any ophthalmological surgical or laser procedure, within the last 6 months, in the eye to be included in thee study. * Previous history of ocular trauma within the last 6 months, in the eye to be included in thee study. * Previous history of chronic uveitis, in the eye to be included in the study. * Previous history of intraocular, periocular, retrobulbar, subconjunctival or sub-tenon injection within the last 6 months, in the eye to be included in the study. * Patients with or that have had silicone present in either the anterior or posterior segments of the eye to be included in the study. * Aphakia in the eye to be included in the study. * Presence of any corneal alteration that may decrease the reliability of Goldmann tonometry in the eye to be included in the study. * Known hypersensitivity to any of the active principles to be used in the study (prostaglandin analogues, β-blockers, α2-agonists, carbonic anhydrase inhibitors). * History of any disease that contraindicates the use of the active principles to be used in the study (asthma, chronic obstructive pulmonary disease (COPD), 2nd or 3rd degree auriculoventricular blockade without pacemaker, sinus bradycardia, manifest cardiac insufficiency, chronic kidney disease with a creatinine clearance \< 30 ml/min). * Requirement of use of monoamineoxidase inhibitors and patients using antidepressants that affect noradrenergic transmission (tricyclic antidepressants and mianserin). * Patients who use, or have used within the las month, steroids applied topically in the eye to be included in the study or through oral, intravenous, intramuscular, dermic, or intralesional administration. * Having participated in clinical trials within 30 days prior to signing this study's informed consent form. * Having participated previously in this study. * Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form. * Having any kind of programmed surgery during the period of this study. * Being or having any immediate family members (spouse, parent/legal tutor, sibling or child) who work either in the investigation center or for the sponsor of this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double blind, multicenter with parallel groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'After signing the informed consent form (ICF), every subject will receive a coded patient number. Randomization will take place through and integrated web response system (IWRS). In the first step, during the eligibility visit, all patients will be assigned the same treatment (Gaap Ofteno PF®). After one month, patients that once again comply with the inclusion criteria will be assigned randomly (1:1) to one of the two investigation products, either Krytantek Ofteno PF® or Eliptic Ofteno PF®.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

2023-12-12