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

• 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.

  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 (9)

• Change in Best Corrected Visual Acuity (BCVA)

  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)

• Changes in optic nerve cup/disc ratio

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

• Change in nerve fibers and ganglion cell thickness

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

• Change in optic nerve image

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

• Change in central corneal thickness

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

Other Outcomes (2)

• Proportion of patients who reached a specific IOP decrease in mmHg

  Days: 60 (± 2) (final visit)

• Proportion of patients who reached a specific IOP decrease in percentage

  Days: 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:

• 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.

You may not qualify if:

• 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).

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

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: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)