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Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

NCT ID: NCT00938704

Last Updated: 2011-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-06-30

Brief Summary

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To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

carboxymethylcellulose 0.5%, glycerin 0.9%

Group Type ACTIVE_COMPARATOR

carboxymethylcellulose 0.5% +glycerin 0.9%

Intervention Type DRUG

To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

2

sodium hyaluronate 0.18%

Group Type ACTIVE_COMPARATOR

sodium hyaluronate 0.18%

Intervention Type DRUG

To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Interventions

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carboxymethylcellulose 0.5% +glycerin 0.9%

To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Intervention Type DRUG

sodium hyaluronate 0.18%

To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Intervention Type DRUG

Other Intervention Names

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Optive™ Sensitive Vismed®

Eligibility Criteria

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Inclusion Criteria

* Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
* Be likely to complete the entire course of study and to comply with appropriate instructions

Exclusion Criteria

* Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
* Have uncontrolled systemic disease
* Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
* Have anticipated contact lens wear during the study
* Have an active ocular infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MA-OPT-09-002

Identifier Type: -

Identifier Source: org_study_id