MedTrace Logo

ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

NCT04523129 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2023-03-10

Study results available
· View outcomes & findings →

Summary

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Conditions

Interventions

DRUG

CyclASol topical ocular, eye drops

Cyclosporine A solution in vehicle

DRUG

Vehicle topical ocular, eye drops

Vehicle

Sponsors & Collaborators

  • Novaliq GmbH

    lead INDUSTRY

Principal Investigators

  • Sonja Kroesser, PhD · Novaliq GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-05
Primary Completion
2021-09-03
Completion
2021-10-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04523129 on ClinicalTrials.gov