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Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno® (PRO-122/I)

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

PRO-122

Krytantek Ofteno®

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Krytantek, Krytantek PF, PRO-122

Eligibility Criteria

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

Inclusion Criteria:

- Clinically healthy
Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2)
Age between 18 to 45 years.
Indistinct sex.
Women must ensure a hormonal contraceptive method or intrauterine device during the study period.
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.
Visual ability 20/30 or better in both eyes.
Vital signs within normal parameters.
Intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

Users of topical ophthalmic products of any kind.
Users of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
Women who are pregnant or breastfeeding.
Participation in clinical research studies 90 days prior to inclusion in the present study.
Previous participation in this same study.
Users of contact lenses.
History of any chronic-degenerative disease.
Inflammatory or infectious disease, active at the time of study entry.
Injuries or traumatisms not resolved at the time of admission to the study.

Sites / Locations

Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRO-122

Krytantek Ofteno®

Arm Description

- Dosage: 1 drop every 12 hours, in both eyes

Outcomes

Primary Outcome Measures

Number of 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. Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort.

Secondary Outcome Measures

Number of Eyes With Epithelial Defects by Grade

The epithelial defects will be evaluated by means of two stains, green lissamine 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 or 1.0 in decimal and the worst 20/200 or 0.1 in decimal number. For the appropriate management of the data, the result of the fraction obtained from the snellen scale is transformed to decimals, in this case subjects close to or equal to 1.0 have better visual acuity while subjects close to or equal to 0.1 have worse visual acuity. The decimal equivalence scale is the result of the division of the fraction obtained in the Snellen chart. where 20/20 = 1.0; Do not confuse with Logmar scale where 20/20 = 0.0 Equivalences Snellen Scale = decimals: 20/200=0.1, 20/100=0.2, 20/50=0.4, 20/40=0.5, 20/30=0.66, 20/25=0.8, 20/20=1.0, etc.

Participants 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.

Participants With 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

NCT03966365

First Posted

May 24, 2019

Last Updated

December 12, 2019

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT03966365

Brief Title

Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®

Acronym

PRO-122/I

Official Title

Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

May 2, 2019 (Actual)

Primary Completion Date

August 30, 2019 (Actual)

Study Completion Date

August 30, 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

Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension. Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects. Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized. Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.

Detailed Description

Number of patients: n = 24 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects. Treatment duration: 7 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). 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

Glaucoma, Krytantek, Krytantek PF, PRO-122

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Phase I clinical trial, controlled, parallel group, double blind, randomized.

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 blind / non-blind teams. 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. Caption "Exclusively for clinical studies" Date of Expiry

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRO-122

Arm Type

Experimental

Arm Description

- Dosage: 1 drop every 12 hours, in both eyes

Arm Title

Krytantek Ofteno®

Arm Type

Active Comparator

Arm Description

- Dosage: 1 drop every 12 hours, in both eyes

Intervention Type

Drug

Intervention Name(s)

PRO-122

Other Intervention Name(s)

timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, Krytantek PF, Krytantek Ofteno® Preservative Free

Intervention Description

PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: topical ophthalmic.

Intervention Type

Drug

Intervention Name(s)

Krytantek Ofteno®

Other Intervention Name(s)

timolol 0.5%, brimonidine 0.2%, dorzolamide 2%

Intervention Description

- 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. - Route of administration: topical ophthalmic.

Primary Outcome Measure Information:

Title

Number of 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 8)

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 8)

Title

Visual Ability

Description

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 8)

Title

Participants With Conjunctival Hyperemia (CH) by Grade

Description

Time Frame

will be evaluated at the end of the treatment, at the final visit (day 8)

Title

Participants With 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 8)

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 8)

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: - Clinically healthy Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2) Age between 18 to 45 years. Indistinct sex. Women must ensure a hormonal contraceptive method or intrauterine device during the study period. 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. Visual ability 20/30 or better in both eyes. Vital signs within normal parameters. Intraocular pressure ≥10 and ≤ 21 mmHg. Exclusion Criteria: Users of topical ophthalmic products of any kind. Users of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women. Women who are pregnant or breastfeeding. Participation in clinical research studies 90 days prior to inclusion in the present study. Previous participation in this same study. Users of contact lenses. History of any chronic-degenerative disease. Inflammatory or infectious disease, active at the time of study entry. Injuries or traumatisms not resolved at the time of admission to the study.

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

Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44190

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

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Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®

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