Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.

NCT06379685 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SOPH190-0923/I
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.

Conditions

Dry Eye; Dry Eyes Chronic; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Incidence Unexpected Related Adverse Reactions

  Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.

  Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.

Secondary Outcomes (6)

• Changes in the ocular comfort index (OCI) score in between interventions

  Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.

• Changes in Best Corrected Visual Acuity (BCVA)

  Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.

• Changes in tear film breakup time

  Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.

• Changes in intraocular pressure (IOP)

  Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.

• Changes in the integrity of the ocular surface (fluorescein staining)

  Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.

Study Arms (2)

PRO-190

EXPERIMENTAL

Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution. Dosage: 1 drop QID \[4\] (4 times per day, at least three hours apart between doses) for 7 days in both eyes, Route of administration: Ophthalmic.

Drug: PRO-190

Systane Ultra®

ACTIVE COMPARATOR

Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution. Dosage: 1 drop QID \[4\] (4 times per day, at least three hours apart between doses) for 7 days in both eyes, Route of administration: Ophthalmic.

Drug: Systane Ultra®

Interventions

PRO-190 DRUG

Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.

PRO-190

Systane Ultra® DRUG

Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.

Systane Ultra®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having the ability to voluntarily give their signed informed consent.
• Clinically healthy subjects.
• Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
• Age ≥ 18 years.
• No history of contact lens wear
• Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \[Tubal Ligation\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the ied consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• Having vital signs within normal parameters.
• Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
• Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

You may not qualify if:

• History of hypersensitivity to any of the components of the drugs under investigation.
• Use of ophthalmic medications from any pharmacological group.
• Use of medications by any other route of administration.
• In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
• Having previously participated in this same study.
• History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.
• Diagnosis of glaucoma or ocular hypertension.
• Known diagnosis of liver or heart disease.
• Presenting active inflammatory or infectious disease at the time of entry into the study.
• Presenting unresolved lesions or traumas at the time of entry into the study.
• Having been subjected to non-ophthalmological surgical procedures in the last 3 months.
• Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.
• Elimination Criteria
• Withdrawal of their consent to participate in the study (informed consent form).
• Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Alejandra Sanchez-Rios, MD

CONTACT

33 3001 4200; alejandra.sanchez@sophia.com.mx

Study Design

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

Model Details: Phase I, controlled, comparative, controlled, comparative.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 23, 2024
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share