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Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

NCT01459588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2019-04-16

Study results available
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Summary

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Carboxymethylcellulose Based Eye Drop Formulation A

Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

DRUG

Carboxymethylcellulose Based Eye Drop Formulation B

Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

DRUG

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

DRUG

Carboxymethylcellulose Based Lubricant Eye Drops

Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2012-02-15
Completion
2012-02-15

Countries

  • United States

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 NCT01459588 on ClinicalTrials.gov