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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280473
• Other study ID #: 11193X-001
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2014
• Est. completion date: March 16, 2015

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: March 16, 2015
• Est. primary completion date: March 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2018 Dec 17. pii: S1367-0484(18)30922-6. doi: 10.1016/j.clae.2018.12.003. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 30
Secondary	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.	Baseline, Day 7
Secondary	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.	Baseline, Day 30
Secondary	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.	Baseline, Day 30
Secondary	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.	Baseline, Day 30