At a glance
ClinicalIndex Comparison Record- ✓Age 18-35 years
- ✓Clinically healthy with no chronic degenerative disease (diabetes, hypertension)
- ✓Best corrected visual acuity ≥20/30 (logMAR 0.2) in both eyes
- ✓Intraocular pressure ≥10 and ≤21 mmHg
- ✕Known allergy or intolerance to atropine eyedrops or antimuscarinic agents
- ✕Currently using any ophthalmic topical products
- ✕Using herbal products or other plant-based supplements through any route
- ✕History of any ocular surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating Atropine Sulfate for Myopia. Completed, enrolled 29 participants across 1 site.
Detailed Summary
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
Study Details
Timeline
Interventions
Administration of one drop QD on both eyes for 14 days.