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

Phase 3

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: Refresh Optive® Gel Drops
Drug: REFRESH LIQUIGEL®

Registration Number: NCT02280473

Lead Sponsor: Allergan

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 188

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Refresh Optive® Gel Drops	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 LIQUIGEL®	REFRESH LIQUIGEL®	REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (10): The Eye Center at Southern College of Optometry
🇺🇸
Memphis, Tennessee, United States
North Bay Eye Associates
🇺🇸
Petaluma, California, United States
Moyes Eye Center, PC
🇺🇸
Kansas City, Missouri, United States
Eye Center Northeast
🇺🇸
Bangor, Maine, United States
Eric M. White, OD, Inc.
🇺🇸
San Diego, California, United States
Ophthalmology Associates
🇺🇸
Saint Louis, Missouri, United States
Comprehensive Eye Care, Ltd.
🇺🇸
Washington, Missouri, United States
Rochester Ophthalmological Group, PC
🇺🇸
Rochester, New York, United States
David W. Ferris & Associates, Inc.
🇺🇸
Warwick, Rhode Island, United States
Primary Eyecare Group, PC
🇺🇸
Brentwood, Tennessee, United States