Comparative Study of the Efficacy of Either Krytantek Oft... | NCT04702789

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

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.

Eligibility Module

Eligibility Criteria

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

PubMed Identifier	Type	Citation	Retractions
40873654	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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). 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 21, 2020	May 12, 2025

Arm/Group Information

ID	Title	Description
BG000	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). 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.
BG001	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). 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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG00114 BG00226

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

V1 Change in IOP 9AM

Title	Measurements
	OG000-4.25± 1.49 OG001-5.17± 2.48

V1 Change in IOP 11AM

Title	Measurements
	OG000

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Mean

Standard Deviation

decimal

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])

ID	Title	Description
OG000	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). 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.

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Mean

Standard Deviation

ratio

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

ID	Title	Description
OG000	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). 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.
OG001	Arm 2; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Mean

Standard Deviation

micrometers

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

ID	Title	Description
OG000	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). 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.
OG001	Arm 2; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Number

participants

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

eyes

ID	Title	Description
OG000	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). 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.
OG001	Arm 2; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Mean

Standard Deviation

micrometers

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

ID	Title	Description
OG000	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). 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.
OG001	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). 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.

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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). 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.

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Count of Participants

Participants

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)

ID	Title	Description
OG000	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). 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.
OG001	Arm 2; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Number

adverse events

Day: 75 (± 3) (safety call)

ID	Title	Description
OG000	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). 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.
OG001	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). 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.

Secondary

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.

This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Posted

Mean

Standard Deviation

score on a scale

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)

ID	Title	Description
OG000	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). 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.
OG001	Arm 2; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®

Other Pre-specified

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.

The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol). Study participants were permitted to include both eyes; accordingly, the number of cases was documented to provide a more precise description of the results from patients with bilateral inclusion.

Posted

Count of Units

Cases (eyes)

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)

Cases (eyes)

ID	Title	Description
OG000	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). 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 Pre-specified

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.

Posted

Count of Units

Cases (eyes)

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)

Cases (eyes)

ID	Title	Description
OG000	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). 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.

Secondary

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)).

This result was calculated using the intention-to-treat (ITT) population, that is, all participants who were randomly assigned and received treatment, regardless of whether they completed the study. When using the ITT population, the number of cases varies across visits, as some participants dropped out of the study during its course.

Posted

Number

cases (eyes)

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)

Cases (eyes)

ID	Title	Description
OG000	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). 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.
OG001

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ocular; 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). 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.	23	23	14	23
EG001	Ocular; 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). 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.	24	24	18	24
EG002	Systemic: 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). 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.	12	12	8	12
EG003	Systemic: 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). 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.	14	14	4	14

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
dry eye	Eye disorders	MedDRA (10.0)	Systematic Assessment	Adverse ocular events are reported in cases (eyes). A total of 23 cases were included, of which 14 involved adverse events in Group 1. In Group 2, there were a total of 24 cases, of which 18 involved adverse events.	EG0003 events3 affected23 at risk EG0012 events2 affected24 at risk EG0020 events0 affected12 at risk EG0030 events0 affected14 at risk
Blepharitis	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0000 events0 affected23 at risk EG0012 events2 affected24 at risk EG0020 events0 affected12 at risk EG003
Conjunctivitis	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0000 events0 affected23 at risk EG0011 events1 affected24 at risk EG0020 events0 affected12 at risk EG003
Ocular paint	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0002 events2 affected23 at risk EG0012 events2 affected24 at risk EG0020 events0 affected12 at risk EG003
Photophobia	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0001 events1 affected23 at risk EG0011 events1 affected24 at risk EG0020 events0 affected12 at risk EG003
Conjunctival hyperemia	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0000 events0 affected23 at risk EG0012 events2 affected24 at risk EG0020 events0 affected12 at risk EG003
Ocular hyperemia	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0002 events2 affected23 at risk EG0014 events4 affected24 at risk EG0020 events0 affected12 at risk EG003
Eye irritation	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0004 events4 affected23 at risk EG0017 events7 affected24 at risk EG0020 events0 affected12 at risk EG003
Increased tearing	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0002 events2 affected23 at risk EG0011 events1 affected24 at risk EG0020 events0 affected12 at risk EG003
Itchy eye	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0004 events4 affected23 at risk EG0019 events9 affected24 at risk EG0020 events0 affected12 at risk EG003
Itching of the eyelid	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0000 events0 affected23 at risk EG0013 events3 affected24 at risk EG0020 events0 affected12 at risk EG003
Eye discharge	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0000 events0 affected23 at risk EG0015 events5 affected24 at risk EG0020 events0 affected12 at risk EG003
Foreign body in the eyes	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0002 events2 affected23 at risk EG0017 events7 affected24 at risk EG0020 events0 affected12 at risk EG003
Blurred vision	Eye disorders		Systematic Assessment	The number of cases (eyes) is recorded	EG0002 events2 affected23 at risk EG0014 events4 affected24 at risk EG0020 events0 affected12 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0024 events4 affected12 at risk EG003
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0021 events1 affected12 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0020 events0 affected12 at risk EG003
Hypoesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0020 events0 affected12 at risk EG003
Gastrointestinal infection	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0021 events1 affected12 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0021 events1 affected12 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment		EG0000 events0 affected23 at risk EG0010 events0 affected24 at risk EG0021 events1 affected12 at risk EG003

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors