Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.

NCT03520348 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH167-0816/I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Title of the study: Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects. Methodology: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory. Goals: To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis: Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its comparator in healthy subjects.

Conditions

Dry Eye; Dry Eye Syndrome of Unspecified Lacrimal Gland

Keywords

dry eye; eye lubricants; eye lubricant gel; PRO-167

Outcome Measures

Primary Outcomes (1)

• Goblet Cell Density (GCD)

  the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter

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

Secondary Outcomes (9)

• Presence of Adverse Events (EAS)

  during the 11 days of evaluation, including the safety call (day 13).

• Intraocular Pressure (IOP)

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

• Breakup Time (BUT)

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

• Chemosis

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

• Ocular Burning (OB)

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

Study Arms (2)

PRO-167

EXPERIMENTAL

Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom

Drug: PRO-167

Corneregel®

ACTIVE COMPARATOR

Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac.

Drug: Corneregel

Interventions

PRO-167 DRUG

Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic

Also known as: dexpanthenol

PRO-167

Corneregel DRUG

Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic

Also known as: dexpanthenol

Corneregel®

Eligibility Criteria

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

You may qualify if:

• Signed informed consent.
• Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
• Age between 18 to 45 years.
• Both genders.
• Blood tests \[complete blood count, blood chemistry of three elements and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
• Vital signs within normal parameters.
• Visual capacity 20/30 or better, in both eyes.
• Intraocular pressure ≥11 and ≤ 21 mmHg.

You may not qualify if:

• Subjects with a history of hypersensitivity to any of the components of the research products.
• Subject users of topical ophthalmic medications of any pharmacological group.
• Subject users of medication by any other route of administration.
• Women who are pregnant or breastfeeding.
• Women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
• Diagnosis of liver disease or triple the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
• Inability to attend or answer the evaluations made in each of the visits.
• Positive smoking (specified as cigarette consumption regardless of quantity and frequency)
• Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period)
• Contact lens users

Sponsors & Collaborators

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

Study Sites (1)

Centro Oftalmológico San Angel

Guadalajara, Jalisco, 44200, 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

Dry Eye Syndromes

Interventions

dexpanthenol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist)
• 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis. The masking will be done using boxes in the primary packaging identical in the two groups. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the allocation number. Blinding may be opened in the following cases: 1. Presence of a serious adverse event. 2. Safety alarm due to the use of the drugs under study. 3. In case the sponsor determines it for any reason of security or other reason that considers pertinent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: October 4, 2017
• Primary Completion: May 22, 2018
• Study Completion: July 16, 2018
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)