Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects

NCT06363292 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH231-1221/I
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.

Conditions

Ophthalmological Agent Toxicity; Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (5)

• Incidence of Unexpected Adverse Events Related to the Interventions

  Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. Adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.

  Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)

• Incidence of Conjunctival Hyperemia

  Any signs of conjunctival hyperemia in between interventions.

  Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)

• Changes in Best Corrected Visual Acuity (BCVA)

  The BCVA will be evaluated through Snellen chart.

  Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

• Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)

  Number of patients with any changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale compared to baseline. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.

  Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

• Changes in the Ocular Comfort Index (OCI) Score Between Interventions.

  The Ocular Comfort Index is a questionnaire designed to measure ocular surface irritation. It assesses symptoms related to comfort in cases of ocular surface disorders. The Ocular Comfort Index is composed of 12 items that assess the frequency and intensity symptoms. Each item is scored on a scale from 0 to 6 (never to always, or absent to severe). The total score becomes a linear continuous interval scale, which ranges from 0 (least symptomatic) to 100 (most symptomatic). The questionnaire was administered to each research subject, allowing them to respond calmly without any pressure and/or coercion. The results were collected using the Ocular Comfort Index calculator \[1\], obtaining a logit score and a 0-100 scale score for each subject. \[1\].- M. E. Johnson, "Measurement of Ocular Surface Irritation on a Linear Interval Scale with the Ocular Comfort Index," Investigative Ophthalmology \& Visual Science, vol. 48, nº 10, 2007.

  Days 0 (Basal Visit), and 8 (Final Visit)

Secondary Outcomes (2)

• Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)

  Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)

• To Assess the Tolerability of PRO-231 Ophthalmic Solution

  Days 3 (Visit 1), 8 (Final Visit)

Study Arms (2)

PRO-231

EXPERIMENTAL

* PRO-231: Moxifloxacin 0.5% Ophthalmic solution. * Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye). * Route of administration: Topical ophthalmic.

Drug: PRO-231

VIGAMOXI®

ACTIVE COMPARATOR

* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution. * Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye). * Route of administration: Topical ophthalmic.

Drug: VIGAMOXI®

Interventions

PRO-231 DRUG

Moxifloxacin 0.5% Ophthalmic solution.

Also known as: Moxifloxacin

PRO-231

VIGAMOXI® DRUG

Moxifloxacin 0.5% Ophthalmic solution.

Also known as: Moxifloxacin

VIGAMOXI®

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)

IIMET Investigación e Innovación en Medicina Traslacional

Guadalajara, Jalisco, 44610, Mexico

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Alejandra Sanchez Rios
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

+ 52 33 3001 4200

Study Officials

• Alejandra Sanchez-Rios, MD

  Regional Medical Affairs Manager

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: January 30, 2024
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)