Clinical trial NCT04702789: Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, multicenter with parallel groups.
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in intraocular Pressure (IOP)
timeFrame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
measure: Changes in optic nerve cup/disc ratio
timeFrame: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
measure: Change in nerve fibers and ganglion cell thickness
timeFrame: Days: 0 (basal visit) and 60 (± 2) (final visit)
measure: Change in optic nerve image
timeFrame: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
measure: Change in central corneal thickness
timeFrame: Days: 0 (basal visit) and 60 (± 2) (final visit)
measure: Change in visual fields
timeFrame: Days: 0 (basal visit) and 60 (± 2) (final visit)
measure: Change in ocular surface integrity (conjunctival hyperemia, chemosis, and corneal fluorescein staining)
timeFrame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
measure: Incidence of adverse events
timeFrame: Day: 75 (± 3) (safety call)
measure: Changes in Ocular Comfort Index
timeFrame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Other outcomes:
measure: Proportion of patients who reached a specific IOP decrease in mmHg
timeFrame: Days: 60 (± 2) (final visit)
measure: Proportion of patients who reached a specific IOP decrease in percentage
timeFrame: Days: 60 (± 2) (final visit)
Locations:
city: Monterrey
country: Mexico
facility: Servicios Médicos y de Investigación Clínica InspirePharma S. de R.L.de C.V.
Study officials:
References: