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A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

NCT02553772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2017-11-17

Study results available
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Summary

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Carboxymethylcellulose Based Eye Drop

Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

DRUG

Carboxymethylcellulose Sodium 0.5%

Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-06
Primary Completion
2016-09-09
Completion
2016-09-09
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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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 NCT02553772 on ClinicalTrials.gov