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

Bacterial Conjunctivitis Clinical Trial

Official title:

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363292
• Other study ID #: SOPH231-1221/I
• Status: Recruiting
• Phase: Phase 1
• Start date: January 30, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: Laboratorios Sophia S.A de C.V.
• Contact: Alejandra Sanchez-Rios, MD
• Phone: 33 3001 4200
• Email: alejandra.sanchez[@]sophia.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Description:

This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include:

Primary (safety):

• Incidence of unexpected adverse events related to the interventions

• Incidence of conjunctival hyperemia and chemosis

• Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart

• Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale.

Primary (tolerability):

• Changes in the ocular comfort index (OCI) score

Secondary (safety):

• Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis).

Secondary (tolerability):

• Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 participated in any clinical research study 30 days prior to inclusion in this study.

• 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.

• Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).

• Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of 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.

• Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).

• Non-tolerability or hypersensitivity to any of the drugs under investigation.

• Adherence < 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• PRO-231
Moxifloxacin 0.5% Ophthalmic solution.
• VIGAMOXI®
Moxifloxacin 0.5% Ophthalmic solution.

Locations

Country	Name	City	State
Mexico	IIMET Investigación e Innovación en Medicina Traslacional	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Primary	Incidence of conjunctival hyperemia and chemosis	Any signs of conjunctival hyperemia and chemosis in between interventions.	Days 3 (Visit 1), and 8 (Final Visit)
Primary	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)
Primary	Changes in the integrity of the ocular surface (fluorescein staining)	Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. 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)
Primary	Changes in the Ocular Comfort Index (OCI) score between interventions.	The subjects will be questioned regarding this symptoms' incidence.	Days 3 (Visit 1), and 8 (Final Visit)
Secondary	Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis)	Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention, excluding conjunctival hyperemia and chemosis.	Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Secondary	To assess the tolerability of PRO-231 ophthalmic solution	To assess the tolerability of PRO-231 ophthalmic solution applied to the ocular surface, in healthy volunteers, versus VIGAMOXI®, by means of: Presence of ocular symptoms (burning, foreign body sensation, pruritus and lacrimation) between interventions.	Days 3 (Visit 1), 8 (Final Visit)