A Phase 4 interventional study of Dorzolamide-timolol-brimonidine and latanoprost and Dorzolamide-timolol and latanoprost in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Laboratorios Sophia S.A de C.V.. Terminated at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 4, Interventional, and Treatment
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
Exclusion Criteria:
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
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
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®
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®
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.
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)
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.
Time frame: 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)
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.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
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.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
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.
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
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.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
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.
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
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.
Time frame: 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)
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.
Time frame: Day: 75 (± 3) (safety call)
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.
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)
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)).
Time frame: 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)
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.
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)
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.
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)
| Milestone | 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® |
|---|---|---|
| Started | 12 | 14 |
| Completed | 5 | 4 |
| Not completed | 7 | 10 |
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.
| mmHg | 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® |
|---|---|---|
| V1 Change in IOP 9AM | -4.25 ± 1.49 | -5.17 ± 2.48 |
| V1 Change in IOP 11AM | -3.31 ± 2.09 | 4.33 ± 3.39 |
| V2 Change in IOP 9AM | -5.94 ± 2.21 | -7.0 ± 3.54 |
| V2 Change in IOP 11AM | -5.69 ± 1.98 | -6.80 ± 2.39 |
| FV Change in IOP 9AM | -5.94 ± 2.34 | -5.0 ± 1.79 |
| FV Change in IOP 11AM | -5.75 ± 2.66 | -5.50 ± 1.38 |
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.
| decimal | 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® |
|---|---|---|
| V1 BVCA | 0.69 ± 0.25 | 0.72 ± 0.23 |
| V2 BVCA | 0.70 ± 0.27 | 0.74 ± 0.20 |
| VF BVCA | 0.79 ± 0.23 | 0.68 ± 0.30 |
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.
| ratio | 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® |
|---|---|---|
| BV Cup/disk ratio | 0.69 ± 0.16 | 0.68 ± 0.22 |
| FV Cup/disk ratio | 0.62 ± 0.17 | 0.72 ± 0.12 |
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.
| micrometers | 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® |
|---|---|---|
| BV Nerve fibers | 80.1 ± 16.0 | 74.4 ± 13.3 |
| BV Ganglion cell thickness | 75.8 ± 15.1 | 69.1 ± 7.20 |
| FV Nerve fibers | 82.6 ± 11.0 | 72.6 ± 10.8 |
| FV Ganglion cell thickness | 79.9 ± 14.7 | 71.7 ± 9.15 |
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.
| participants | 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® |
|---|---|---|
| BV "Small" Optic Nerve | 0 | 2 |
| BV "Medium" Optic Nerve | 8 | 8 |
| BV "Large" Optic Nerve | 4 | 4 |
| FV "Small" Optic Nerve | 0 | 0 |
| FV "Medium" Optic Nerve | 12 | 14 |
| FV "Large" Optic Nerve | 0 | 0 |
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.
| micrometers | 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® |
|---|---|---|
| BV CCT | 536 ± 42.7 | 518 ± 32.9 |
| FV CCT | 540 ± 57.5 | 528 ± 27.4 |
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.
| score on a scale | 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® |
|---|---|---|
| BV Change in visual field | -4.25 ± 6.69 | -7.50 ± 8.33 |
| FV Change in visual field | -0.80 ± 5.47 | -3.08 ± 4.05 |
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.
| Participants | 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® |
|---|---|---|
| BV Chemosis (Absent or not absent) — Present | 0 | 0 |
| BV Chemosis (Absent or not absent) — Absent | 12 | 14 |
| V1 Chemosis — Present | 0 | 0 |
| V1 Chemosis — Absent | 12 | 14 |
| V2 Chemosis — Present | 0 | 0 |
| V2 Chemosis — Absent | 12 | 14 |
| FV Chemosis — Present | 0 | 0 |
| FV Chemosis — Absent | 12 | 14 |
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.
| adverse events | 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® |
|---|---|---|
| Number of Adverse Events | 32 | 43 |
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.
| score on a scale | 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® |
|---|---|---|
| Eligibility visit | 30.5 ± 15.7 | 30.1 ± 5.7 |
| Basal visit | 33.2 ± 8.84 | 27.2 ± 8.68 |
| first follow-up visit | 39.2 ± 12.8 | 29.4 ± 5.90 |
| second follow-up visit | 33.0 ± 10.9 | 29.1 ± 7.97 |
| final visit | 29.8 ± 17.6 | 23.6 ± 15.6 |
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.
| Cases (eyes) | 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® |
|---|---|---|
| V1 9AM — ≤ 12 mmHg | 0 | 0 |
| V1 9AM — ≤ 13 mmHg | 0 | 2 |
| V1 9AM — ≤ 14 mmHg | 4 | 0 |
| V1 9AM — ≤ 15 mmHg | 1 | 0 |
| V1 9AM — ≤ 18 mmHg | 2 | 3 |
| V1 9AM — ≥ 19 mmHg | 1 | 1 |
| V1 11AM — ≤ 12 mmHg | 0 | 1 |
| V1 11AM — ≤ 13 mmHg | 0 | 1 |
| V1 11AM — ≤ 14 mmHg | 4 | 0 |
| V1 11AM — ≤ 15 mmHg | 0 | 1 |
| V1 11AM — ≤ 18 mmHg | 3 | 2 |
| V1 11AM — ≥ 19 mmHg | 1 | 1 |
| V2 9AM — ≤ 12 mmHg | 2 | 2 |
| V2 9AM — ≤ 13 mmHg | 3 | 0 |
| V2 9AM — ≤ 14 mmHg | 1 | 0 |
| V2 9AM — ≤ 15 mmHg | 1 | 1 |
| V2 9AM — ≤ 18 mmHg | 1 | 2 |
| V2 9AM — ≥ 19 mmHg | 0 | 0 |
| V2 11AM — ≤ 12 mmHg | 2 | 2 |
| V2 11AM — ≤ 13 mmHg | 3 | 0 |
| V2 11AM — ≤ 14 mmHg | 2 | 0 |
| V2 11AM — ≤ 15 mmHg | 0 | 1 |
| V2 11AM — ≤ 18 mmHg | 1 | 2 |
| V2 11AM — ≥ 19 mmHg | 0 | 0 |
| VF 9AM — ≤ 12 mmHg | 3 | 0 |
| VF 9AM — ≤ 13 mmHg | 2 | 0 |
| VF 9AM — ≤ 14 mmHg | 0 | 2 |
| VF 9AM — ≤ 15 mmHg | 0 | 1 |
| VF 9AM — ≤ 18 mmHg | 3 | 3 |
| VF 9AM — ≥ 19 mmHg | 0 | 0 |
| VF 11AM — ≤ 12 mmHg | 5 | 1 |
| VF 11AM — ≤ 13 mmHg | 0 | 0 |
| VF 11AM — ≤ 14 mmHg | 0 | 0 |
| VF 11AM — ≤ 15 mmHg | 2 | 1 |
| VF 11AM — ≤ 18 mmHg | 1 | 2 |
| VF 11AM — ≥ 19 mmHg | 0 | 0 |
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.
| Cases (eyes) | 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® |
|---|---|---|
| V1 9AM — < 20% | 4 | 2 |
| V1 9AM — ≥ 20% | 0 | 1 |
| V1 9AM — ≥ 25% | 2 | 1 |
| V1 9AM — ≥ 30% | 2 | 0 |
| V1 9AM — ≥ 35% | 0 | 2 |
| V1 11AM — < 20% | 4 | 2 |
| V1 11AM — ≥ 20% | 2 | 1 |
| V1 11AM — ≥ 25% | 0 | 1 |
| V1 11AM — ≥ 30% | 2 | 1 |
| V1 11AM — ≥ 35% | 0 | 1 |
| V2 9AM — < 20% | 1 | 1 |
| V2 9AM — ≥ 20% | 1 | 0 |
| V2 9AM — ≥ 25% | 0 | 1 |
| V2 9AM — ≥ 30% | 3 | 1 |
| V2 9AM — ≥ 35% | 3 | 2 |
| V2 11AM — < 20% | 1 | 0 |
| V2 11AM — ≥ 20% | 0 | 0 |
| V2 11AM — ≥ 25% | 2 | 2 |
| V2 11AM — ≥ 30% | 2 | 1 |
| V2 11AM — ≥ 35% | 3 | 2 |
| VF 9AM — < 20% | 2 | 2 |
| VF 9AM — ≥ 20% | 1 | 0 |
| VF 9AM — ≥ 25% | 0 | 2 |
| VF 9AM — ≥ 30% | 1 | 2 |
| VF 9AM — ≥ 35% | 4 | 0 |
| VF 11AM — < 20% | 2 | 0 |
| VF 11AM — ≥ 20% | 1 | 1 |
| VF 11AM — ≥ 25% | 0 | 4 |
| VF 11AM — ≥ 30% | 1 | 0 |
| VF 11AM — ≥ 35% | 4 | 1 |
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)).
| cases (eyes) | 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® |
|---|---|---|
| BV Conjunctival Hyperemia : Normal (0) | 6 | 4 |
| BV Conjunctival Hyperemia : Very mild (I) | 12 | 12 |
| BV Conjunctival Hyperemia : Mild (II) | 4 | 6 |
| BV Conjunctival Hyperemia : Moderate (III) | 1 | 2 |
| BV Conjunctival Hyperemia : Severe (III) | 0 | 0 |
| V1 Conjunctival Hyperemia : Normal (0) | 4 | 0 |
| V1 Conjunctival Hyperemia : Very mild (I) | 11 | 13 |
| V1 Conjunctival Hyperemia : Mild (II) | 3 | 8 |
| V1 Conjunctival Hyperemia : Moderate (III) | 1 | 2 |
| V1 Conjunctival Hyperemia : Severe (III) | 0 | 0 |
| V2 Conjunctival Hyperemia : Normal (0) | 4 | 2 |
| V2 Conjunctival Hyperemia : Very mild (I) | 8 | 7 |
| V2 Conjunctival Hyperemia : Mild (II) | 5 | 4 |
| V2 Conjunctival Hyperemia : Moderate (III) | 0 | 3 |
| V2 Conjunctival Hyperemia : Severe (III) | 0 | 0 |
| FV Conjunctival Hyperemia : Normal (0) | 4 | 2 |
| FV Conjunctival Hyperemia : Very mild (I) | 6 | 2 |
| FV Conjunctival Hyperemia : Mild (II) | 1 | 2 |
| FV Conjunctival Hyperemia : Moderate (III) | 0 | 3 |
| FV Conjunctival Hyperemia : Severe (III) | 0 | 0 |
Collected over From day 0 (basal visit) to the safety call on day 75 (±3 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocular; Dorzolamide-timolol-brimonidine and Latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® | 0/23 (0%) | 0/23 (0%) | 14/23 (60.9%) |
| Ocular; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® | 0/24 (0%) | 0/24 (0%) | 18/24 (75%) |
| Systemic: Dorzolamide-timolol-brimonidine and Latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Systemic: Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® | 0/14 (0%) | 0/14 (0%) | 4/14 (28.6%) |
| Event | Ocular; Dorzolamide-timolol-brimonidine and Latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® | Ocular; Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® | Systemic: Dorzolamide-timolol-brimonidine and Latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® | Systemic: Dorzolamide-timolol and Latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® |
|---|---|---|---|---|
| Itchy eyeEye disorders | 4/23 | 9/24 | 0/12 | 0/14 |
| HeadacheNervous system disorders | 0/23 | 0/24 | 4/12 | 2/14 |
| Eye irritationEye disorders | 4/23 | 7/24 | 0/12 | 0/14 |
| Foreign body in the eyesEye disorders | 2/23 | 7/24 | 0/12 | 0/14 |
| Eye dischargeEye disorders | 0/23 | 5/24 | 0/12 | 0/14 |
| Ocular hyperemiaEye disorders | 2/23 | 4/24 | 0/12 | 0/14 |
| Blurred visionEye disorders | 2/23 | 4/24 | 0/12 | 0/14 |
| dry eyeEye disorders | 3/23 | 2/24 | 0/12 | 0/14 |
| Itching of the eyelidEye disorders | 0/23 | 3/24 | 0/12 | 0/14 |
| Ocular paintEye disorders | 2/23 | 2/24 | 0/12 | 0/14 |
| Age, Categorical(Participants) | 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® | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 5 | 9 |
| >=65 years | 8 | 9 | 17 |
| Age, Continuous(years) | 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® | Total |
|---|---|---|---|
| Mean | 63.0 ± 12.2 | 70.9 ± 7.9 | 67.3 ± 10.73 |
| Sex: Female, Male(Participants) | 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® | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 4 | 5 | 9 |
| Race and Ethnicity Not Collected(Participants) | 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® | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | 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® | Total |
|---|---|---|---|
| Mexico | 12 | 14 | 26 |
| Best Corrected Visual Acuity (BCVA)(decimals) | 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® | Total |
|---|---|---|---|
| Mean | 0.71 ± 0.26 | 0.71 ± 0.21 | 0.71 ± 0.23 |
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Laboratorios Sophia S.A de C.V.