A Phase 2 Trial to Test Safety and Efficacy of ST-100, a Unique Collagen Mimetic Peptide Ophthalmic Solution for Dry Eye Disease.

ABSTRACT:

Objective

Dry eye disease (DED) is a worldwide source of ocular discomfort. This first-in-human phase 2 clinical study determined the efficacy of treating signs and symptoms of DED using an ophthalmic solution of synthesized mimetic of human collagen (ST-100).

Design

This double-masked, randomized, study compared high (60 μg/mL) and low (22 μg/mL) dose ST-100 to vehicle utilizing the Ora, Inc. Controlled Adverse Environment (CAE) during a 28-day period.

Participants

Participants included males and females ≥ 18 years of age with signs and symptoms of DED for ≥ 6 months that worsened during CAE exposure who were not taking any topical prescription therapeutic.

Intervention

Participants applied ST-100 or vehicle placebo topically to both corneas (1 drop) twice dai

SUBMITTER: Baratta RO 

PROVIDER: S-EPMC10838901 | biostudies-literature | 2024 May-Jun

REPOSITORIES: biostudies-literature