A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

April 9, 2019 updated by: Allergan
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 3

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

    • California
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates
      • San Diego, California, United States, 92123
        • Eric M. White, OD, Inc.
    • Maine
      • Bangor, Maine, United States, 04401
        • Eye Center Northeast
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Moyes Eye Center, PC
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Associates
      • Washington, Missouri, United States, 63090
        • Comprehensive Eye Care, Ltd.
    • New York
      • Rochester, New York, United States, 14618
        • Rochester Ophthalmological Group, PC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • David W. Ferris & Associates, Inc.
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Primary Eyecare Group, PC
      • Memphis, Tennessee, United States, 38104
        • The Eye Center at Southern College of Optometry

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 product
  • Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

  • Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
  • Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
  • Current eye infection or inflammation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Active Comparator: REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Time Frame: Baseline, Day 30
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 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the OSDI© Score
Time Frame: Baseline, Day 7
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 7
Change From Baseline in Tear Break-up Time (TBUT)
Time Frame: Baseline, Day 30
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). The eye with shorter average TBUT at baseline is reported for each patient.
Baseline, Day 30
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Time Frame: Baseline, Day 30
The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.
Baseline, Day 30
Change From Baseline in the Schirmer Test
Time Frame: Baseline, Day 30
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.
Baseline, Day 30

Collaborators and Investigators

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

Sponsor

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.

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 (Actual)

November 13, 2014

Primary Completion (Actual)

March 16, 2015

Study Completion (Actual)

March 16, 2015

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Dry Eye Syndromes

Clinical Trials on Refresh Optive® Gel Drops

Subscribe