A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

Phase 3

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: Carboxymethylcellulose Sodium 0.5%
Drug: Carboxymethylcellulose Based Eye Drop

Registration Number: NCT02553772

Lead Sponsor: Allergan

Brief Summary: This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 242

Inclusion Criteria

Used artificial tears for dry eye
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
Herpes keratitis in the last 6 months
Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REFRESH OPTIVE® ADVANCED	Carboxymethylcellulose Sodium 0.5%	Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
OM3 Tear	Carboxymethylcellulose Based Eye Drop	Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score	Baseline, Day 90	The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Schirmer Test	Baseline, Day 90	The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).
Change From Baseline in Tear Break-up Time (TBUT)	Baseline, Day 90	TBUT is defined as 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. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.
Change From Baseline in Corneal Staining Score	Baseline, Day 90	Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in Conjunctival Staining Score	Baseline, Day 90	Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

Trial Locations

Locations (13): Havana Research Institute LLC
🇺🇸
Burbank, California, United States
The University of New South Wales School of Optometry and Vision Science
🇦🇺
Sydney, Australia
Lugene Eye Institute
🇺🇸
Glendale, California, United States
Rochester Ophthalmological Group, PC
🇺🇸
Rochester, New York, United States
Prof. M.T. Coroneo Pty. Ltd.
🇦🇺
Randwick, Australia
Department of Optometry & Vision Sciences, The University of Melbourne
🇦🇺
Parkville, Australia
The Private Practice of Milton Hom, OD
🇺🇸
Azusa, California, United States
Eric M. White, OD, INC
🇺🇸
San Diego, California, United States
Moyes Eye Center, PC
🇺🇸
Kansas City, Missouri, United States
Texan Eye
🇺🇸
Austin, Texas, United States
Scott and Christie and Associate
🇺🇸
Cranberry Township, Pennsylvania, United States
Ophthalmology Associates
🇺🇸
Saint Louis, Missouri, United States
Charlotte Eye Ear Nose
🇺🇸
Charlotte, North Carolina, United States