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Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

NCT05481489 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-07-01

No results posted yet for this study

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

Interventions

DRUG

Atropine Sulfate

Atropine Sulfate 0.05% Ophthalmic Solution

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-03-31
Completion
2023-04-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481489 on ClinicalTrials.gov