Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials.

ABSTRACT:

Purpose

The purpose of this study was to evaluate the safety and tolerability profile of drugs used for treating common eye disorders when applied to normal healthy volunteers (NHVs) as explored in phase 1 trials.

Subjects and methods

A total of 166 NHVs were identified in six phase 1 trials, examined in a retrospective analysis. The primary endpoints were visual comfort (by ocular comfort index, OCI) and safety (laboratory evaluations, vital signs (VS), visual acuity (VA), intraocular pressure (IOP), lissamine green and fluorescein staining, conjunctival hyperemia, chemosis, and adverse events' incidence (AE)).

Results

Compared to baseline, 75.9%, 40.4% and 73.7% of NHV (for lubricant, hypotensive and antibiotic treatments, respectively) improved their OCI score by t

SUBMITTER: Munoz-Villegas P 

PROVIDER: S-EPMC8544558 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature