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

NCT04702789 | Terminated Phase 4 Results

• 1 other identifier: SOPH122-0420/IV
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Best Corrected Visual Acuity (BCVA)

  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)

  Days: 0 (basal visit) and 60 (± 2) (final visit)

• Mean Value in Nerve Fibers and Ganglion Cell Thickness

  Days: 0 (basal visit) and 60 (± 2) (final visit)

• Optic Nerve Image

  Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)

• Central Corneal Thickness (CCT)

  Days: 0 (basal visit) and 60 (± 2) (final visit)

Other Outcomes (2)

• Percentage of Cases Who Reached a Specific IOP Decrease in mmHg

  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

  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)

Study Arms (2)

Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF®

EXPERIMENTAL

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

Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

EXPERIMENTAL

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

Interventions

Dorzolamide-timolol-brimonidine and latanoprost DRUG

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.

Also known as: PRO-122, Krytantek Ofteno PF®, Gaap Ofteno PF®

Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF®

Dorzolamide-timolol and latanoprost DRUG

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.

Also known as: Eliptic Ofteno PF®, Gaap Ofteno PF®

Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

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

Monterrey, Mexico

Location

Related Publications (1)

• 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.

  PMID: 40873654 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost; dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

It was estimated that a sample of 90 cases was required (45 cases per treatment group, population PP). Since this objective was not met, due to the loss of subjects and deviations greater than 30% from the protocol (PP= 14 cases)(26 participants), this report does not include comparisons between treatment groups. For all variables, an exploratory analysis of the data was performed.

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

:+52 (33) 3001 4200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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®.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, multicenter with parallel groups.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: October 19, 2021
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)