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

A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Carboxymethylcellulose Based Eye Drop; Drug: Carboxymethylcellulose Sodium 0.5%

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Parkville, Australia, VIC 3010
    • Department of Optometry & Vision Sciences, The University of Melbourne
  • Randwick, Australia, NSW 2031
    • Prof. M.T. Coroneo Pty. Ltd.
  • Sydney, Australia, NSW 2052
    • The University of New South Wales School of Optometry and Vision Science
• United States
  • California
    • Azusa, California, United States, 91702
      • The Private Practice of Milton Hom, OD
    • Burbank, California, United States, 91506
      • Havana Research Institute LLC
    • Glendale, California, United States, 91204
      • Lugene Eye Institute
    • San Diego, California, United States, 92123
      • Eric M. White, OD, INC
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center, PC
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott and Christie and Associate
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye

Participation Criteria

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:

• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OM3 Tear; 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.	Drug: Carboxymethylcellulose Based Eye Drop; Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Active Comparator: REFRESH OPTIVE® ADVANCED; 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.	Drug: 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.; Other Names: REFRESH OPTIVE® ADVANCED

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	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.	Baseline, Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Tear Break-up Time (TBUT)	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.	Baseline, Day 90
Change From Baseline in Corneal Staining Score	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).	Baseline, Day 90
Change From Baseline in Conjunctival Staining Score	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).	Baseline, Day 90
Change From Baseline in the Schirmer Test	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).	Baseline, Day 90

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Actual): September 9, 2016
• Study Completion (Actual): September 9, 2016

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Gastrointestinal Agents; Pharmaceutical Solutions; Laxatives; Ophthalmic Solutions; Carboxymethylcellulose Sodium
• Other Study ID Numbers: 11182X-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No