Trial Outcomes & Findings for Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification (NCT NCT03693989)

NCT ID: NCT03693989

Last Updated: 2019-12-02

Results Overview

The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The result of the Snellen fraction will be transformed to its decimal equivalent in LogMAR, ex. 20/20= 1.0, 20/25=0.8, 20/40= 0.5, 20/200= 1.0, etc. The subjects will be averaged by group.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 178 participants
• Primary outcome timeframe: day 28 at the final visit
• Results posted on: 2019-12-02

Participant Flow

Participant milestones

Measure	PRO-145. Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Overall Study STARTED	88	90
Overall Study COMPLETED	85	86
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	PRO-145. Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Overall Study Protocol Violation	3	4

Baseline Characteristics

Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification

Baseline characteristics by cohort

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic	Total n=171 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 11.6 • n=5 Participants	64.7 years STANDARD_DEVIATION 12.4 • n=7 Participants	65.48 years STANDARD_DEVIATION 11.93 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	49 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	85 Participants n=5 Participants	86 Participants n=7 Participants	171 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	85 participants n=5 Participants	86 participants n=7 Participants	171 participants n=5 Participants

PRIMARY outcome

Timeframe: day 28 at the final visit

Population: the analysis was performed per protocol (PP)

The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The result of the Snellen fraction will be transformed to its decimal equivalent in LogMAR, ex. 20/20= 1.0, 20/25=0.8, 20/40= 0.5, 20/200= 1.0, etc. The subjects will be averaged by group.

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Visual Ability (VA)	0.91 units on a scale (LogMAR) Standard Deviation 0.1	0.87 units on a scale (LogMAR) Standard Deviation 0.2

PRIMARY outcome

Timeframe: day 28 at the final visit

Population: The analysis of the study was per protocol

The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection.

the number of cases with adverse events will be reported per study arm

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Adverse Events	93 cases	89 cases

SECONDARY outcome

Timeframe: day 28 at the final visit

Population: The analysis of the study was per protocol

unit: degrees, Direct observation (Biomicroscopy).

Scale for anterior chamber cellularity. Grade/Number of cells

Grade / Number of cells

0 Any

½ + 1-5

1. + 6-15

2. + 16-25

3. + 26-60

4. + More than 60

the cellularity will be measured according to the scale that is added next, considering as normal the degree 0, and abnormal any other degree.

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Cellularity in the Anterior Chamber grade 4	0 Participants	0 Participants
Cellularity in the Anterior Chamber Grade 0	75 Participants	76 Participants
Cellularity in the Anterior Chamber Grade 1/2	8 Participants	6 Participants
Cellularity in the Anterior Chamber grade 1	2 Participants	4 Participants
Cellularity in the Anterior Chamber grade 2	0 Participants	0 Participants
Cellularity in the Anterior Chamber grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: day 28 at the final visit

Population: The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.

The evaluation of clinical edema will be evaluated by the Efron scale, which is a series of factorial sections of the cornea, including features such as grooves and folds. The Efron scale has a strong correlation with variations in intensity. The number will be reported according to the rating awarded.

Efron Scale: 0 Normal, 1 very slight, 2 mild, 3 moderate and 4 severe.

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Clinical Corneal Edema Moderate (3)	0 Participants	0 Participants
Clinical Corneal Edema Severe (4)	0 Participants	0 Participants
Clinical Corneal Edema Normal (0)	85 Participants	83 Participants
Clinical Corneal Edema Very mild (1)	0 Participants	3 Participants
Clinical Corneal Edema Mild (2)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: day 28 at the final visit

In the presence of intraocular inflammation, the increased permeability of the non-pigmented layer of the ciliary epithelium, the posterior epithelium of the iris and the vascular endothelium of the iris results in the accumulation of cells and proteins (visible to the examiner as flare) in the anterior chamber. Using a light beam of 0.2mm X 0.2mm directed obliquely to the anterior chamber with a forward inclination of the light source (slit lamp tower) the degree of flare and cellularity will be determined according to the group of work of standardization for the nomenclature of uveitis.

Flare scale

0 There is no flare

1. + Mild

2. + Moderate (iris and crystalline clearly visible)

3. + Marking (iris and crystalline slightly blurred)

4. + More than 60 (fibrin)

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Flare 4+	0 Participants	0 Participants
Flare 0	84 Participants	86 Participants
Flare 1+	1 Participants	0 Participants
Flare 2+	0 Participants	0 Participants
Flare 3+	0 Participants	0 Participants

SECONDARY outcome

Timeframe: day 28 at the final visit

Population: The analysis of the study was per protocol

By means of optical coherence tomography (OCT) the Retinal central thickness (GCR) will be measured. OCT is a noninvasive imaging test that uses light waves to take photographs of the cross section of the retina (the light-sensitive tissue that lines the back of the eye).With a OCT, each of the characteristic layers of the retina can be observed, allowing mapping and measuring its thickness a micrometer result will be obtained and the analysis will be carried out between groups.

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Central Thickness of the Retina	253.59 microns Standard Error 26.9	263.38 microns Standard Error 36.4

SECONDARY outcome

Timeframe: day 28 at the final visit

Population: The analysis of the study was per protocol

Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity, we will use the Efron scale for conjunctival hyperemia.

0 normal

1. very slight

2. mild

3. moderate

4. severe

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Conjunctival Hyperemia Normal (0)	78 Participants	73 Participants
Conjunctival Hyperemia Very mild (1)	5 Participants	11 Participants
Conjunctival Hyperemia Mild (2)	2 Participants	2 Participants
Conjunctival Hyperemia Moderate (3)	0 Participants	0 Participants
Conjunctival Hyperemia Severe (4)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: day 28 at the final visit

Population: The analysis of the study was per protocol

Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Intraocular Pressure	13.88 mmHg Standard Deviation 3.0	13.04 mmHg Standard Deviation 2.4

SECONDARY outcome

Timeframe: day 28 at the final visit

Population: The analysis of the study was per protocol

The subject will be questioned if after applying the medication he felt burning, pruritus, a foreign body sensation and blurred vision.

Presence or absence: it will be marked as present (1) or absent (0) for each of the symptoms questioned

Outcome measures

Measure	PRO-145. n=85 Participants Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 Participants Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Symptomatology Post Instillation burning eyes	12 Participants	8 Participants
Symptomatology Post Instillation foreign body sensation eyes	0 Participants	2 Participants
Symptomatology Post Instillation blurred vision	2 Participants	3 Participants
Symptomatology Post Instillation itching eyes	1 Participants	0 Participants

Adverse Events

PRO-145.

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Prednefrin

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	PRO-145. n=85 participants at risk Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 participants at risk Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Vascular disorders acute myocardial infarction	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	0.00% 0/86 • Adverse events were monitored throughout the study, for at least 10 months.

Other adverse events

Measure	PRO-145. n=85 participants at risk Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.	Prednefrin n=86 participants at risk Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V. Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic
Gastrointestinal disorders stomach ache	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders ocular pain	2.4% 2/85 • Number of events 2 • Adverse events were monitored throughout the study, for at least 10 months.	2.3% 2/86 • Number of events 2 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders eyelid inflammation	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders tearing	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	0.00% 0/86 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders neovascular macular membrane	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders myodesopsia	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders red eye	3.5% 3/85 • Number of events 3 • Adverse events were monitored throughout the study, for at least 10 months.	7.0% 6/86 • Number of events 6 • Adverse events were monitored throughout the study, for at least 10 months.
Ear and labyrinth disorders earache	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Skin and subcutaneous tissue disorders paresthesia	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders eye itching	8.2% 7/85 • Number of events 7 • Adverse events were monitored throughout the study, for at least 10 months.	7.0% 6/86 • Number of events 6 • Adverse events were monitored throughout the study, for at least 10 months.
Respiratory, thoracic and mediastinal disorders rhinorrhea	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders eye foreign body sensation	17.6% 15/85 • Number of events 15 • Adverse events were monitored throughout the study, for at least 10 months.	12.8% 11/86 • Number of events 11 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders chemosis	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders Diabetic Macular Edema	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Infections and infestations pharyngotonsillitis	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders Photophobia	3.5% 3/85 • Number of events 3 • Adverse events were monitored throughout the study, for at least 10 months.	3.5% 3/86 • Number of events 3 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders ocular hypertension	2.4% 2/85 • Number of events 2 • Adverse events were monitored throughout the study, for at least 10 months.	0.00% 0/86 • Adverse events were monitored throughout the study, for at least 10 months.
Infections and infestations urinary tract infection	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	0.00% 0/86 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders ocular burning	54.1% 46/85 • Number of events 46 • Adverse events were monitored throughout the study, for at least 10 months.	40.7% 35/86 • Number of events 35 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders blepharospasm	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Nervous system disorders headache	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	3.5% 3/86 • Number of events 3 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders anterior chamber cellularity	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders infectious conjunctivitis	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	0.00% 0/86 • Adverse events were monitored throughout the study, for at least 10 months.
Infections and infestations flu	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	2.3% 2/86 • Number of events 2 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders Irvine-Gass syndrome	0.00% 0/85 • Adverse events were monitored throughout the study, for at least 10 months.	1.2% 1/86 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.
General disorders head trauma	1.2% 1/85 • Number of events 1 • Adverse events were monitored throughout the study, for at least 10 months.	0.00% 0/86 • Adverse events were monitored throughout the study, for at least 10 months.
Eye disorders Blurred Vision	10.6% 9/85 • Number of events 9 • Adverse events were monitored throughout the study, for at least 10 months.	9.3% 8/86 • Number of events 8 • Adverse events were monitored throughout the study, for at least 10 months.

Additional Information

Dr. Ricardo Llamas (clinical safety pharmacologist)

Laboratorios Sophia

Phone: +52 (33) 3001 4200

Email: ricardo.llamas@sophia.com.mx

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place