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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)

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status

Recruiting

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Dorzolamide-timolol-brimonidine and latanoprost

Dorzolamide-timolol and latanoprost

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

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

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Best Corrected Visual Acuity (BCVA)

With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc.

Changes in optic nerve cup/disc ratio

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.

Change 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.

Change in 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.

Change in central corneal thickness

Measured through ultrasonic pachymetry, three assessments will be performed, these and its average will be recorded.

Change in visual fields

Visual fields will be evaluated with a SITA standard automated white-on-white perimetry performed with a Humphrey perimeter. To be considered reliable, fixation losses, false positives and false negatives must be under 20%. Mean deviation (MD) and pattern standard deviation (PSD) will be recorded.

Change in ocular surface integrity (conjunctival hyperemia, chemosis, and corneal fluorescein staining)

By means of a slit lamp, conjunctival hyperemia, chemosis, and corneal fluorescein staining 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)). 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. Fluorescein staining evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).

Incidence 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.

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.

Full Information

NCT ID

NCT04702789

First Posted

January 7, 2021

Last Updated

December 26, 2022

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT04702789

Brief Title

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

Acronym

PRO-122

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double blind, multicenter with parallel groups.

Masking

ParticipantInvestigator

Masking Description

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®.

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Dorzolamide-timolol-brimonidine and latanoprost

Other Intervention Name(s)

PRO-122, Krytantek Ofteno PF®, Gaap Ofteno PF®

Intervention Description

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

Intervention Name(s)

Dorzolamide-timolol and latanoprost

Other Intervention Name(s)

Eliptic Ofteno PF®, Gaap Ofteno PF®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in intraocular Pressure (IOP)

Description

Time Frame

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 Measure Information:

Title

Change in Best Corrected Visual Acuity (BCVA)

Description

Time Frame

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)

Title

Changes in optic nerve cup/disc ratio

Description

Time Frame

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

Title

Change in nerve fibers and ganglion cell thickness

Description

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.

Time Frame

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

Title

Change in optic nerve image

Description

Through a fundus camera a photograph will be taken to obtain a faithful record of any possible changes to the optic nerve head characteristics.

Time Frame

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

Title

Change in central corneal thickness

Description

Measured through ultrasonic pachymetry, three assessments will be performed, these and its average will be recorded.

Time Frame

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

Title

Change in visual fields

Description

Time Frame

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

Title

Change in ocular surface integrity (conjunctival hyperemia, chemosis, and corneal fluorescein staining)

Description

Time Frame

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)

Title

Incidence of adverse events

Description

Time Frame

Day: 75 (± 3) (safety call)

Title

Changes in Ocular Comfort Index

Description

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.

Time Frame

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)

Other Pre-specified Outcome Measures:

Title

Proportion of patients who reached a specific IOP decrease in mmHg

Description

Patients who reached IOP within the following ranges: ≤12, ≤13, ≤14, ≤15, or ≤18.

Time Frame

Days: 60 (± 2) (final visit)

Title

Proportion of patients who reached a specific IOP decrease in percentage

Description

Patients who demonstrated decrease in IOP within the following percentage ranges: ≥ 20%, ≥ 25%, ≥ 30%, y ≥ 35%

Time Frame

Days: 60 (± 2) (final visit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alejandra Sanchez-Rios, MD

Phone

+52 3330014200

Ext

1190

alejandra.sanchez@sophia.com.mx

Facility Information:

Facility Name

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

City

Monterrey

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manuel Alejandro De Alba-Castilla, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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