Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo.

NCT06352541 | Completed Phase 1 DMC

• 1 other identifier: SOPH232-0824/I
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Incidence Unexpected Related Adverse Reactions

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

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

• Changes in intraocular pressure (IOP)

  Previous instillation of topical anesthetic, the IOP (right eye) will be measured through a Goldmann tonometer during visits

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

• Incidence of Stinging

  The subjects will be questioned regarding this symptom's incidence (right eye), frecuency, duration and severity will not be considered, only its incidence will.

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

Secondary Outcomes (4)

• Incidence of Expected Related Adverse Events

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

• Changes in Best Corrected Visual Acuity (BCVA)

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

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

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

• Incidence of ocular symptoms (foreign body sensation and tearing)

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

Study Arms (2)

PRO-232

EXPERIMENTAL

* PRO-232. Moxifloxacin 0.5% y Dexamethasone Phosphate 0.1% Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days on right eye.

Drug: PRO-232

Placebo

PLACEBO COMPARATOR

* Placebo. Sodium Chloride. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days on right eye.

Other: Placebo

Interventions

PRO-232 DRUG

Moxifloxacin 0.5% and Dexamethasone Phosphate 0.1%

PRO-232

Placebo OTHER

Vehicle Control, ophthalmic solution

Placebo

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)

Investigacion e Innovacion en Medicina Traslacional

Mexico City, Mexico

Location

Study Design

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

Model Details: Phase I, controlled, comparative, parallel groups, double blind, one center.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: February 8, 2024
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)