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

Last updated: December 5, 2023
Sponsor: Laboratorios Sophia S.A de C.V.
Overall Status: Terminated

Phase

4

Condition

Ocular Hypertension

Vascular Diseases

Williams Syndrome

Treatment

Dorzolamide-timolol-brimonidine and latanoprost

Dorzolamide-timolol and latanoprost

Clinical Study ID

NCT04702789
SOPH122-0420/IV
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with diagnosed primary open angle glaucoma or ocular hypertension, not usinga 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 daysprevious 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 inthis study.
  • Being capable of voluntarily grant a signed informed consent.
  • Being willing and able to meet the requirements of the study such as attendingprogrammed visits, treatment plan and other study procedures.
  • Age ≥18 years old.

Exclusion

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 contraceptivemethod, intrauterine device or bilateral tubal obstruction.
  • Anterior chamber angle < 2 in Shaffer's scale, or presence of peripheral anteriorsynechia, 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 centralsites), in the eye to be included in the study.
  • Having a previous history of any ophthalmological surgical or laser procedure, withinthe 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 includedin 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-tenoninjection 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 posteriorsegments 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 Goldmanntonometry 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 beused in the study (asthma, chronic obstructive pulmonary disease (COPD), 2nd or 3rddegree auriculoventricular blockade without pacemaker, sinus bradycardia, manifestcardiac insufficiency, chronic kidney disease with a creatinine clearance < 30ml/min).
  • Requirement of use of monoamineoxidase inhibitors and patients using antidepressantsthat affect noradrenergic transmission (tricyclic antidepressants and mianserin).
  • Patients who use, or have used within the las month, steroids applied topically in theeye 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'sinformed consent form.
  • Having participated previously in this study.
  • Previous history of drug addiction within the last 2 years prior to signing thisstudy'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 orchild) who work either in the investigation center or for the sponsor of this study.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Dorzolamide-timolol-brimonidine and latanoprost
Phase: 4
Study Start date:
October 19, 2021
Estimated Completion Date:
November 23, 2023

Connect with a study center

  • Servicios Médicos y de Investigación Clínica InspirePharma S. de R.L.de C.V.

    Monterrey,
    Mexico

    Site Not Available

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