Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

July 22, 2015 updated by: Allergan
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
  • Ability/agreement to wear habitual correction (glasses) during study period

Exclusion Criteria:

  • Known allergy or sensitivity to the study product(s) or its components
  • Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
  • Chronic use of systemic medications which may affect a dry eye condition
  • Active ocular allergy or infection
  • Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
  • Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glycerin and Polysorbate 80 based artificial tear
Drug: Glycerin and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Other Names:
  • Refresh Dry Eye Therapy® Lubricant Eye Drops
Experimental: Artificial Tears Formulation 1
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
Drug: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear
1-2 drops in each eye, as needed, but at least twice daily
Experimental: Artificial Tears Formulation 2
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Drug: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
1-2 drops in each eye, as needed, but at least twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
Time Frame: Baseline (Day 1), Day 90
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
Baseline (Day 1), Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
Time Frame: Baseline (Day 1), Day 90
Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Baseline (Day 1), Day 90
Change From Baseline in Tear Break-up Time (TBUT) at Day 90
Time Frame: Baseline (Day 1), Day 90
Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Baseline (Day 1), Day 90
Change From Baseline in Corneal Staining at Day 90
Time Frame: Baseline (Day 1), Day 90
Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Baseline (Day 1), Day 90
Change From Baseline in Conjunctival Staining Severity Score at Day 90
Time Frame: Baseline (Day 1), Day 90
Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Baseline (Day 1), Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG9965-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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