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

NCT03966365 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH122-0518/I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Glaucoma; Krytantek; Krytantek PF; PRO-122

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (4)

• Number of Eyes With Epithelial Defects by Grade

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

• Visual Ability

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

• Participants With Conjunctival Hyperemia (CH) by Grade

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

• Participants With Chemosis

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

Other Outcomes (1)

• Changes in Intraocular Pressure

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

Study Arms (2)

PRO-122

EXPERIMENTAL

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

Drug: PRO-122

Krytantek Ofteno®

ACTIVE COMPARATOR

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

Drug: Krytantek Ofteno®

Interventions

PRO-122 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.

Also known as: timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, Krytantek PF, Krytantek Ofteno® Preservative Free

PRO-122

Krytantek Ofteno® 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.

Also known as: timolol 0.5%, brimonidine 0.2%, dorzolamide 2%

Krytantek Ofteno®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44190, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34707360 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: PhD. Ricardo Llamas
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: May 2, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)