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Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan® (PRO-179/I)

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

PRO 179

Travatan 0.004 % Ophthalmic Solution

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Travoprost, ophthalmic solution, Prostaglandin Analogues, Antiglaucoma drugs, glaucoma

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Jose Navarro Partida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRO-179

Travatan®

Arm Description

Dosage: 1 drop every 24 hours, at night, in both eyes.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

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.

Eye Comfort Index

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).

Secondary Outcome Measures

Number of Eyes With Epithelial Defects by Grade

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

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.

Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade

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

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.

Full Information

NCT ID

NCT03965052

First Posted

May 23, 2019

Last Updated

November 21, 2019

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT03965052

Brief Title

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

Acronym

PRO-179/I

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

April 24, 2019 (Actual)

Primary Completion Date

July 2, 2019 (Actual)

Study Completion Date

August 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Glaucoma

Keywords

Travoprost, ophthalmic solution, Prostaglandin Analogues, Antiglaucoma drugs, glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

double blind, with randomization.

Masking

InvestigatorOutcomes Assessor

Masking Description

Blinding will correspond to the principal investigator and coinvestigator. In addition, the statistical analysis will be carried out in a blinded manner for the final analysis. Blinding can not be guaranteed in the subject. The masking will be done through the secondary container. The primary packaging will not be masked by the morphological difference between them. The sponsor and the research center will have two teams blinded / not blinded. They will be identified by means of identical labels. Which, in accordance with current and applicable regulations, must contain at least: Name, address and telephone number of the sponsor. Pharmaceutical form and route of administration. Lot Number. Legend "Exclusively for clinical studies" Date of Expiry.

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRO-179

Arm Type

Experimental

Arm Description

Dosage: 1 drop every 24 hours, at night, in both eyes.

Arm Title

Travatan®

Arm Type

Active Comparator

Arm Description

Dosage: 1 drop every 24 hours, at night, in both eyes.

Intervention Type

Drug

Intervention Name(s)

PRO 179

Other Intervention Name(s)

PRO-179, Bristrio®, Travoprost 0.004% ophthalmic solution

Intervention Description

Generic name: Travoprost Distinctive denomination: Bristrio® (PRO-179) Active principles: Travoprost 0.004%. Pharmaceutical form: Ophthalmic solution Presentation: multi-dose dropper bottle, 2.5 milliliters. Prepared by: Sophia Laboratories, S.A. of C.V. Description of the solution: transparent solution, free of visible particles. Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.

Intervention Type

Drug

Intervention Name(s)

Travatan 0.004 % Ophthalmic Solution

Other Intervention Name(s)

Travoprost 0.004% ophthalmic solution

Intervention Description

Generic name: Travoprost Distinctive denomination: Travatan® Active ingredients: Travoprost 0.004% Pharmaceutical form: Ophthalmic solution. Presentation: multi-dose dropper bottle, 2.5 milliliters. Prepared by: Alcon Laboratories Inc. Description of the solution: transparent solution, free of visible particles. Consult information to prescribe.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

during the 14 days of evaluation, including the safety call (day 14).

Title

Eye Comfort Index

Description

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 11)

Secondary Outcome Measure Information:

Title

Number of Eyes With Epithelial Defects by Grade

Description

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 11)

Title

Visual Ability

Description

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 11)

Title

Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade

Description

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 11)

Title

Number of Eyes of Chemosis

Description

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.

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 11)

Other Pre-specified Outcome Measures:

Title

Changes in Intraocular Pressure

Description

the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 11)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leopoldo Baiza Durán, MD

Organizational Affiliation

Laboratorios Sophia S.A de C.V.

Official's Role

Study Director

Facility Information:

Facility Name

Jose Navarro Partida

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

45160

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34707360

Citation

Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.

Results Reference

derived

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

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