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

NCT ID: NCT03966365

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-02
• Study Completion Date: 2019-08-30

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.

Conditions

Glaucoma

Keywords

Glaucoma; Krytantek; Krytantek PF; PRO-122

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRO-122

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

Group Type: EXPERIMENTAL

PRO-122

Intervention Type: DRUG

• 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.

Krytantek Ofteno®

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

Group Type: ACTIVE_COMPARATOR

Krytantek Ofteno®

Intervention Type: DRUG

• - 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.

Interventions

PRO-122

• 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

Krytantek Ofteno®

• - 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.

Intervention Type: DRUG

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leopoldo Baiza Durán, MD

Role: STUDY_DIRECTOR

Laboratorios Sophia S.A de C.V.

Locations

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

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 34707360 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOPH122-0518/I

Identifier Type: -

Identifier Source: org_study_id