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CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

NCT02617667 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2019-11-06

Study results available
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Summary

The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Cyclosporine A

topical ocular, eye drops

DRUG

Placebo

topical ocular, eye drops

Sponsors & Collaborators

  • Novaliq GmbH

    lead INDUSTRY

Principal Investigators

  • Sonja Kroesser, Dr.sc.hum. · Novaliq GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02617667 on ClinicalTrials.gov