Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel

NCT03697876 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH165-0217/I
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects. Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects. Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant

Conditions

Dry Eye Syndromes

Keywords

PRO-165; sodium hyaluronate; Chondroitin sulfate 0.18%

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  The Principal Investigator will register the Events Adverse (EA) that the subjects of the study will present. The EAs will be expressed as absent or present and the number of cases will be counted by study group.

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

• Ocular 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). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.

  Baseline Visit (day 0) and Final Visit (day 11)

Secondary Outcomes (5)

• Visual Acuity (VA)

  Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11)

• Intraocular Pressure (IOP)

  Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).

• Number of Participants With Post-instillation Symptomatology

  Final Visit (day 11)

• Tear Breakup Time (TBUT)

  Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).

• Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale)

  Baseline Visit (day 0), Visit 1 (day 5), and Final Visit (day 11).

Study Arms (2)

PRO-165

EXPERIMENTAL

Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac

Drug: PRO-165

1. Artelac® Nightime Gel

ACTIVE COMPARATOR

Dose: one drop of gel, 4 times a day during the waking period, in the bottom of the right eye sac

Interventions

PRO-165 DRUG

PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.

Also known as: sodium hyaluronate 0.2%, chondroitin sulfate + sodium hyaluronate, chondroitin sulfate 0.18%

PRO-165

Artelac DRUG

Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.

Also known as: Carbomer 0.2%

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, three element blood chemistry 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. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute)
• 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 lactating.
• Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
• Known diagnosis of liver disease
• Inability to attend or answer the evaluations made in each of the visits.
• Positive tobacco use (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.
• 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 entry into the study.

Sponsors & Collaborators

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

Study Sites (1)

Leslie victoria Aguilar Saldaña

Mexico City, Mexico City, 07020, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

chondroitin sulfate, sodium hyaluronate drug combination; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Alejandra Sanchez-Ríos
• Organization: Laboratorios Sophia S.A. de C.V.

alejandra.sanchez@sophia.com.mx

3330014500

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: PARTICIPANT, INVESTIGATOR
• 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 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: controlled, of parallel groups, double blind, randomized, exploratory

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: August 20, 2018
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: January 9, 2026
• Results First Posted: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)