Study of ST-100 as Treatment for Dry Eye Disease

NCT05241470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-03-13

Study results available
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Summary

The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.

Conditions

Interventions

DRUG

ST-100 Ophthalmic Solution

One drop in each eye twice a day

DRUG

Placebo Ophthalmic Solution

One drop in each eye twice a day

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY
  • Stuart Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert O Baratta, MD · Stuart Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-10-11
Completion
2021-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT05241470 on ClinicalTrials.gov