Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF

NCT06370585 | Completed Phase 1 DMC

• 1 other identifier: SOPH229-0823/I
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.

Conditions

Dry Eye Disease; Ocular Surface Disease

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), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.

Secondary Outcomes (5)

• Changes in Best Corrected Visual Acuity (BCVA)

  Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

• Changes in ocular surface staining using SICCA ocular staining score scale

  Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

• Incidence of chemosis

  Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

• Incidence of grade 3 or 4 conjunctival hyperemia.

  Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.

• Adherence to treatment (adherence)

  Through an average of 8 days. This evaluations will take place on days 8 (Final Visit) after the inclusion of each subject.

Study Arms (2)

PRO-229

EXPERIMENTAL

* Dexpanthenol 2% and sodium hyaluronate 0.15% ophthalmic solution. * Dosage:1 drop QID \[4\] (four times per day) for 7 days on right both eyes. * Route of administration: Ophthalmic. * Presentation: Multidose dropper bottle.

Drug: PRO-229

Lagricel® Ofteno PF

ACTIVE COMPARATOR

* Sodium hyaluronate 0.4%. Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days on right both eyes. * Route of administration: Ophthalmic. * Presentation: Multidose dropper bottle.

Drug: Lagricel® Ofteno PF

Interventions

PRO-229 DRUG

\- Dexpanthenol 2% and sodium hyaluronate 0.15% ophthalmic solution.

PRO-229

Lagricel® Ofteno PF DRUG

\- Sodium hyaluronate 0.4%. Ophthalmic solution.

Lagricel® Ofteno PF

Eligibility Criteria

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

You may qualify if:

• Having the ability to voluntarily give their signed informed consent.
• Ophthalmologically and clinically healthy subjects.
• Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
• Age between 18 to 45 years.
• Male or female gender.
• 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 informed consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
• Corneal staining ≤ grade I on the Oxford Scale.
• Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

You may not qualify if:

• History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or 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.
• Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
• History of eye surgery in the last 6 months.
• Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Asociacion Mexicana para la Investigacion Clinica

Pachuca, Hidalgo, 42070, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

CD5L protein, human

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 17, 2024
• Study Start: May 16, 2024
• Primary Completion: July 25, 2024
• Study Completion: November 13, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)