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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carboxymethylcellulose Based Eye Drop
Carboxymethylcellulose Sodium 0.5%
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:

  • 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

Sites / Locations

  • The Private Practice of Milton Hom, OD
  • Havana Research Institute LLC
  • Lugene Eye Institute
  • Eric M. White, OD, INC
  • Moyes Eye Center, PC
  • Ophthalmology Associates
  • Rochester Ophthalmological Group, PC
  • Charlotte Eye Ear Nose
  • Scott and Christie and Associate
  • Texan Eye
  • Department of Optometry & Vision Sciences, The University of Melbourne
  • Prof. M.T. Coroneo Pty. Ltd.
  • The University of New South Wales School of Optometry and Vision Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OM3 Tear

REFRESH OPTIVE® ADVANCED

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).
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).

Full Information

First Posted
September 16, 2015
Last Updated
October 18, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02553772
Brief Title
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 6, 2016 (Actual)
Primary Completion Date
September 9, 2016 (Actual)
Study Completion Date
September 9, 2016 (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 of a new eye drop formulation 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
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OM3 Tear
Arm Type
Experimental
Arm Description
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.
Arm Title
REFRESH OPTIVE® ADVANCED
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboxymethylcellulose Based Eye Drop
Intervention Description
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Intervention Type
Drug
Intervention Name(s)
Carboxymethylcellulose Sodium 0.5%
Other Intervention Name(s)
REFRESH OPTIVE® ADVANCED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Description
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.
Time Frame
Baseline, Day 90
Secondary Outcome Measure Information:
Title
Change From Baseline in Tear Break-up Time (TBUT)
Description
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.
Time Frame
Baseline, Day 90
Title
Change From Baseline in Corneal Staining Score
Description
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).
Time Frame
Baseline, Day 90
Title
Change From Baseline in Conjunctival Staining Score
Description
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).
Time Frame
Baseline, Day 90
Title
Change From Baseline in the Schirmer Test
Description
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).
Time Frame
Baseline, Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
The Private Practice of Milton Hom, OD
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Havana Research Institute LLC
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
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
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
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Charlotte Eye Ear Nose
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Scott and Christie and Associate
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Department of Optometry & Vision Sciences, The University of Melbourne
City
Parkville
ZIP/Postal Code
VIC 3010
Country
Australia
Facility Name
Prof. M.T. Coroneo Pty. Ltd.
City
Randwick
ZIP/Postal Code
NSW 2031
Country
Australia
Facility Name
The University of New South Wales School of Optometry and Vision Science
City
Sydney
ZIP/Postal Code
NSW 2052
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

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

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