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

NCT03965052 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH179-0818/I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.(0: None discomfort, 100: high discomfort).

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

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 11)

• Visual Ability

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

• Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade

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

• Number of Eyes of Chemosis

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

Other Outcomes (1)

• Changes in Intraocular Pressure

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

Study Arms (2)

PRO-179

EXPERIMENTAL

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

Drug: PRO 179

Travatan®

ACTIVE COMPARATOR

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

Drug: Travatan 0.004 % Ophthalmic Solution

Interventions

PRO 179 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.

Also known as: PRO-179, Bristrio®, Travoprost 0.004% ophthalmic solution

PRO-179

Travatan 0.004 % Ophthalmic Solution 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.

Also known as: Travoprost 0.004% ophthalmic solution

Travatan®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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.

Sponsors & Collaborators

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

Study Sites (1)

Jose Navarro Partida

Guadalajara, Jalisco, 45160, 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

Interventions

Travoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

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 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double blind, with randomization.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: April 24, 2019
• Primary Completion: July 2, 2019
• Study Completion: August 29, 2019
• Last Updated: December 12, 2019
• Results First Posted: December 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)