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

NCT ID: NCT04702789

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2023-11-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Dorzolamide-timolol-brimonidine and latanoprost

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Dorzolamide-timolol and latanoprost

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

PRO-122; Krytantek Ofteno PF®; Gaap Ofteno PF®; Eliptic Ofteno PF®; Gaap Ofteno PF®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Monterrey, , Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 40873654 (View on PubMed)

Other Identifiers

SOPH122-0420/IV

Identifier Type: -

Identifier Source: org_study_id