Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution (PRO-230)

Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.

Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)

Study Overview

• Status: Withdrawn
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine Sulfate

Detailed Description

A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire.

The presence of non-expected AE < 10% will deem PRO-230 as safe; while an incidence of photophobia < 30% will deem PRO-230 as tolerable.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being clinically healthy
• Ability to voluntarily sign an informed consent form (ICF).
• Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
• Age between 18 and 35.
• Absence of history of contact lens use.
• Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.
• Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
• Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
• Presenting vital signs within normal parameters.
• Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion Criteria:

• Using any kind of ophthalmic topical products.
• Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
• Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
• For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
• Having participated in any clinical study 90 days prior to the inclusion in this study.
• Having participated in this clinical study.
• History of any chronic degenerative disease, including diabetes and hypertension.
• Presenting active inflammatory or infectious diseases when entering this study.
• Presenting unresolved lesions or trauma when entering this study.
• History of any ocular surgery.
• History of any surgery, non-ocular, within the previous 3 months of entering this studies.
• Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO-230; Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days.	Drug: Atropine Sulfate; Atropine Sulfate 0.05% Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of unexpected adverse events	The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.	Through Day 21 ± 1 (Safety Call)
Incidence of photophobia	The number of cases of photophobia.	Through Day 21 ± 1 (Safety Call)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillary Diameter	Change of pupillary diameter after exposure to the investigation product.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
Incidence of expected adverse events	The number of adverse events presented that are previously described / known for the active substance in this pharmaceutic form and concentration.	Through Day 21 ± 1 (Safety Call)
Measurement of the change in best near corrected visual acuity (BNCVA)	The change in BNCVA after exposure to investigation product, compared to basal value.	Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the change in best corrected visual acuity (BCVA)	The change in BCVA after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Changes in intraocular pressure (IOP)	The change in IOP after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Incidence of corneal and conjunctival staining	Presence of corneal and conjunctival staining with fluorescein and lissamine green after exposure to investigation product.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
Measurement of vital signs (blood pressure)	The change in blood pressure after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Measurement of vital signs (heart rate)	The change in heart rate after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Value of the ocular comfort index (OCI) questionnaire	The change ocular comfort index (OCI) questionnaire results after exposure to investigation product, compared to basal value.	Days: 1 (Basal Visit), 16 ± 1 (Final Visit)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2023
• Primary Completion (Estimated): March 31, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: SOPH230-1121/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No