Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

NCT05481489 | Withdrawn Phase 1 DMC

• 1 other identifier: SOPH230-1121/I
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pupillary Diameter

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

• Incidence of expected adverse events

  Through Day 21 ± 1 (Safety Call)

• Measurement of the change in best near corrected visual acuity (BNCVA)

  Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

Other Outcomes (6)

• Measurement of the change in best corrected visual acuity (BCVA)

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

• Changes in intraocular pressure (IOP)

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

• Incidence of corneal and conjunctival staining

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

Study Arms (1)

PRO-230

EXPERIMENTAL

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

Interventions

Atropine Sulfate DRUG

Atropine Sulfate 0.05% Ophthalmic Solution

PRO-230

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I, non comparative, open, unicentric.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: February 1, 2023
• Primary Completion: March 31, 2023
• Study Completion: April 24, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share