Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®

Phase 1

Completed

Conditions: Glaucoma

Interventions: Drug: PRO 179
Drug: Travatan 0.004 % Ophthalmic Solution

Registration Number: NCT03965052

Lead Sponsor: Laboratorios Sophia S.A de C.V.

Brief Summary: Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.

Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.

Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.

Detailed Description: Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.

duration: 10 days.

Duration of subject in the study: 15 to 22 days.

Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.

The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).

Statistical methodology:

The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2) or Fisher's exact. An alpha ≤ 0.05 will be considered significant.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Be clinically healthy.
Have the ability to give their signed informed consent and show willingness to comply with the study procedures
Have an age between 18 to 45 years.
Indistinct sex.
Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
Present blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.

Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.

Blood chemistry of three elements (QS): Glucose, urea and creatinine.
Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.
- Present visual ability 20/30 or better in both eyes.
- Present vital signs within normal parameters.
- Present intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria

Be a user of topical ophthalmic products of any kind.
Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
In case of being a woman, being pregnant or breastfeeding.
Have participated in clinical research studies 90 days prior to inclusion in the present study.
Have previously participated in this same study.
Be a user of contact lenses and can not suspend their use during the study.
That they can not follow the lifestyle considerations described in section 6.2.2
Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.
Having a history of any chronic-degenerative disease.
Present inflammatory or infectious disease, active at the time of admission to the study.
Present injuries or unresolved traumas at the time of entering the study.
Having the antecedent of any type of eye surgery.
Having undergone surgical procedures, not ophthalmological, in the last 3 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRO-179	PRO 179	Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan®	Travatan 0.004 % Ophthalmic Solution	Dosage: 1 drop every 24 hours, at night, in both eyes.

Primary Outcome Measures

Name	Time	Method
Eye Comfort Index	will be evaluated at the end of the treatment, at the final visit (day 11)	It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).
Number of Participants With Adverse Events	during the 14 days of evaluation, including the safety call (day 14).	primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade	will be evaluated at the end of the treatment, at the final visit (day 11)	Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Number of Eyes of Chemosis	will be evaluated at the end of the treatment, at the final visit (day 11)	The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Number of Eyes With Epithelial Defects by Grade	will be evaluated at the end of the treatment, at the final visit (day 11)	The epithelial defects will be evaluated by means of two stains, lissamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Visual Ability	will be evaluated at the end of the treatment, at the final visit (day 11)	The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding. Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10. Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc.