Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension. (PRO-122)

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.

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

Study Overview

• Status: Terminated
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Dorzolamide-timolol-brimonidine and latanoprost; Drug: Dorzolamide-timolol and latanoprost

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant, breastfeeding, or planning to become pregnant during the clinical study.
• For women of reproductive age, not using a hormonal contraceptive method, intrauterine device, or bilateral tubal ligation.
• Anterior chamber angle < 2 in the Shaffer Classification or presence of peripheral anterior synechiae in the eye to be included in the study.
• Currently undergoing treatment with any systemic ocular hypotensive agent (e.g., mannitol, glycerin, isosorbide).
• 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.
• 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.
• 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.
• 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).
• 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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF®; Application of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Krytantek Ofteno® (dorzolamide 2%, timolol 0.5% and brimonidine 0.2%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days).	Drug: Dorzolamide-timolol-brimonidine and latanoprost; Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Krytantek Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.; Other Names: PRO-122; Krytantek Ofteno PF®; Gaap Ofteno PF®
Experimental: Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®; Application of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Eliptic Ofteno® (dorzolamide 2% and timolol 0.5%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days).	Drug: Dorzolamide-timolol and latanoprost; Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Eliptic Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.; Other Names: Gaap Ofteno PF®; Eliptic Ofteno PF®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intraocular Pressure (IOP)	Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated at 9:00 and at 11:00 hrs. (± 30 minutes). Both measurements and their average will be registered. Normal values are considered between 10 and 21 mmHg. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Ocular Comfort Index	Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.	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)
Best Corrected Visual Acuity (BCVA)	Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome. BCVA was compared between groups and between visits. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.	Days: -30 (± 2) (eligibility visit), 0 (basal visit [BV]), 14 (± 2) (first follow-up visit [V1]), 30 (± 2) (second follow-up visit [V2]) and 60 (± 2) (final visit [FV])
Optic Nerve Cup/Disc Ratio (Baseline Vist vs Final Visit)	Both clinical and imaging evaluation will be performed. For clinical evaluation, after the application of a topical ophthalmic mydriatic (tropicamide 0.8% / phenylephrine 5%), indirect ophthalmoscopy will be performed through the aid of a fundus lens in a slit lamp. For imaging, optic coherence tomography (OCT) will be used. Assessed and reported only for the basal visit and final visit.	Days: 0 (basal visit) and 60 (± 2) (final visit)
Mean Value in Nerve Fibers and Ganglion Cell Thickness	Spectral domain OCT is a non invasive tool that will be used to evaluate quantitatively the thickness of retinal nerve fibers and ganglion cell layers. The mean observed in the nerve fibers and ganglion cell thickness was calculated. This was assessed and reported only for the basal and final visit.	Days: 0 (basal visit) and 60 (± 2) (final visit)
Optic Nerve Image	Through a fundus camera a photograph will be taken to obtain a faithful record of any possible changes to the optic nerve head characteristics. Its classification as "small", "medium" or "large" relied on the expertise of the PI, the percentage of cases in each classification ("small", "medium" or "large") was reported. Assessed and reported only for the basal visit and final visit.	Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
Central Corneal Thickness (CCT)	Measured through ultrasonic pachymetry, three assessments will be performed, these and its average will be recorded. Assessed and reported for the basal visit and final visit.	Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in Visual Fields	Visual fields will be assessed using standard automated SITA (Swedish Interactive Thresholding Algorithm) white-on-white perimetry performed with a Humphrey perimeter. To be considered reliable, fixation losses, false positives, and false negatives must be less than 20%. The mean deviation (MD) was recorded, which is a measure of overall field loss. The standard deviation of the pattern was also recorded, which is a measure of focal loss or variability within the field. A higher score is a worse result. The theoretical value or reported range for the average deviation is from +2.00 to -35 dB.	Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in Ocular Surface Integrity (Chemosis)	By means of a slit lamp chemosis will be evaluated. Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent. The number and percentage of participants in each category was reported.	Days: 0 (basal visit, BV), 14 (± 2) (first follow-up visit, V1), 30 (± 2) (second follow-up visit, V2) and 60 (± 2) (final visit, FV)
Number of Adverse Events	Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.	Day: 75 (± 3) (safety call)
Change in Ocular Surface Integrity (Conjunctival Hyperemia)	By means of a slit lamp conjunctival hyperemia will be evaluated. Conjunctival hyperemia will be graded according to Efron's scale (5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4)).	Days: 0 (basal visit, BV), 14 (± 2) (first follow-up visit, V1), 30 (± 2) (second follow-up visit, V2) and 60 (± 2) (final visit, FV)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Cases Who Reached a Specific IOP Decrease in mmHg	Percentage of cases who reached a reduction in IOP within the following ranges: ≤12, ≤13, ≤14, ≤15, or ≤18 mmHg. Each range is a classification and the percentage is calculated with the counts of cases in each classification. PIO was assessed in the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, and was reported for the first follow-up visit, second follow-up visit, and final visit. The initial objective of the study was to report the percentage of patients who achieved a specific reduction in intraocular pressure (IOP). However, because the study ended early, the number of participants was limited, and both eyes per patient were included, we chose to present the full dataset in order to provide a more comprehensive report.	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)
Percentage of Cases Who Reached a Specific IOP Decrease in Percentage	Cases who demonstrated decrease in IOP within the following percentage ranges: ≥ 20%, ≥ 25%, ≥ 30%, y ≥ 35%. Each range is a classification and the percentage is calculated with the counts of cases in each classification. PIO was assessed in the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, and was reported for the first follow-up visit, second follow-up visit, and final visit.	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)

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.

Publications and helpful links

General Publications

• Olvera-Montano O, Mejia-Morales C, Jauregui-Franco RO, Gomez-Mendez SC, Munoz-Villegas P. Maximum Tolerated Medical Therapy for Glaucoma: Fixed-Dose Combinations of Timolol, Dorzolamide, Brimonidine with Latanoprost Versus Timolol, Dorzolamide with Latanoprost. Clin Ophthalmol. 2025 Aug 22;19:2913-2925. doi: 10.2147/OPTH.S540312. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Fatty Acids; Lipids; Biological Factors; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Latanoprost; dorzolamide-timolol combination
• Other Study ID Numbers: SOPH122-0420/IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No