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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Refresh Optive® Gel Drops
REFRESH LIQUIGEL®
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Bay Eye Associates
  • Eric M. White, OD, Inc.
  • Eye Center Northeast
  • Moyes Eye Center, PC
  • Ophthalmology Associates
  • Comprehensive Eye Care, Ltd.
  • Rochester Ophthalmological Group, PC
  • David W. Ferris & Associates, Inc.
  • Primary Eyecare Group, PC
  • The Eye Center at Southern College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Refresh Optive® Gel Drops

REFRESH LIQUIGEL®

Arm Description

Refresh Optive® Gel Drops; 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.

Outcomes

Primary Outcome Measures

Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
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.

Secondary Outcome Measures

Change From Baseline in the OSDI© Score
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.
Change From Baseline in Tear Break-up Time (TBUT)
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.
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
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.
Change From Baseline in the Schirmer Test
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.

Full Information

First Posted
October 29, 2014
Last Updated
April 9, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02280473
Brief Title
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 13, 2014 (Actual)
Primary Completion Date
March 16, 2015 (Actual)
Study Completion Date
March 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refresh Optive® Gel Drops
Arm Type
Experimental
Arm Description
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Arm Title
REFRESH LIQUIGEL®
Arm Type
Active Comparator
Arm Description
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Intervention Type
Drug
Intervention Name(s)
Refresh Optive® Gel Drops
Intervention Description
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Intervention Type
Drug
Intervention Name(s)
REFRESH LIQUIGEL®
Intervention Description
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Primary Outcome Measure Information:
Title
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Description
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.
Time Frame
Baseline, Day 30
Secondary Outcome Measure Information:
Title
Change From Baseline in the OSDI© Score
Description
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.
Time Frame
Baseline, Day 7
Title
Change From Baseline in Tear Break-up Time (TBUT)
Description
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.
Time Frame
Baseline, Day 30
Title
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Description
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.
Time Frame
Baseline, Day 30
Title
Change From Baseline in the Schirmer Test
Description
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.
Time Frame
Baseline, Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Eric M. White, OD, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Eye Center Northeast
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Moyes Eye Center, PC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
David W. Ferris & Associates, Inc.
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Primary Eyecare Group, PC
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
The Eye Center at Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30573298
Citation
Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, Carlisle-Wilcox C, Vehige J, Haque S. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study. Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17.
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A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

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