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

NCT ID: NCT03965052

Last Updated: 2019-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2019-08-29

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.

Conditions

Glaucoma

Keywords

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

Study Design

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

Study Groups

PRO-179

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

Group Type: EXPERIMENTAL

PRO 179

Intervention Type: DRUG

• 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.

Travatan®

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

Group Type: ACTIVE_COMPARATOR

Travatan 0.004 % Ophthalmic Solution

Intervention Type: DRUG

• 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.

Interventions

PRO 179

• 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

Travatan 0.004 % Ophthalmic Solution

• 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.

Intervention Type: DRUG

Other Intervention Names

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

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.

• 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

Jose Navarro Partida

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

SOPH179-0818/I

Identifier Type: -

Identifier Source: org_study_id