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A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
carboxymethylcellulose 0.5%/glycerin 0.9%
sodium hyaluronate 0.18%
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:

  • Use of artificial tears for dry eye in both eyes for at least 3 months
  • Use of preservative-free artificial tears at least twice daily for 2 weeks;

Exclusion Criteria:

  • Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
  • Use of punctal plugs or contact lenses in the last month
  • Active ocular allergy within last 2 years
  • Best corrected visual acuity (BCVA) less than 20/200 in either eye

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

OPTIVE FUSION™

VISMED® Multi

Arm Description

1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Outcomes

Primary Outcome Measures

Change From Baseline in Global Ocular Staining Score in the Study Eye
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.

Secondary Outcome Measures

Change From Baseline in Global Ocular Staining Score in the Study Eye
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. 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 and a positive number change from baseline represents a worsening.
Change From Baseline in the Schirmer Test in the Study Eye
The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Work Productivity and Activity Impairment Questionnaire Score
The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Change From Baseline in Corneal Staining in the Study Eye
The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Change From Baseline in Conjunctival Staining in the Study Eye
The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Conjunctival Hyperaemia in the Study Eye
Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).
Study Product Use
The number of times the study product is administered per day is recorded.

Full Information

First Posted
April 16, 2014
Last Updated
April 9, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02117687
Brief Title
A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 14, 2014 (Actual)
Primary Completion Date
January 27, 2015 (Actual)
Study Completion Date
March 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPTIVE FUSION™
Arm Type
Active Comparator
Arm Description
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Arm Title
VISMED® Multi
Arm Type
Active Comparator
Arm Description
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose 0.5%/glycerin 0.9%
Other Intervention Name(s)
OPTIVE FUSION™
Intervention Description
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Intervention Type
Drug
Intervention Name(s)
sodium hyaluronate 0.18%
Other Intervention Name(s)
VISMED® Multi
Intervention Description
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Global Ocular Staining Score in the Study Eye
Description
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Time Frame
Baseline, Day 35
Secondary Outcome Measure Information:
Title
Change From Baseline in Global Ocular Staining Score in the Study Eye
Description
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Time Frame
Baseline, Month 3
Title
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Description
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. 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 and a positive number change from baseline represents a worsening.
Time Frame
Baseline, Day 35
Title
Change From Baseline in the Schirmer Test in the Study Eye
Description
The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Time Frame
Baseline, Day 35
Title
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Description
Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
Time Frame
Baseline, Day 35, Month 3
Title
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Description
Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).
Time Frame
Baseline, Day 35, Month 3
Title
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Description
Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
Time Frame
Day 35
Title
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Description
Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
Time Frame
Day 35, Month 3
Title
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
Description
TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Time Frame
Baseline, Day 35
Title
Work Productivity and Activity Impairment Questionnaire Score
Description
The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame
Baseline, Day 35, Month 3
Title
Change From Baseline in Corneal Staining in the Study Eye
Description
The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Time Frame
Baseline, Day 35, Month 3
Title
Change From Baseline in Conjunctival Staining in the Study Eye
Description
The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Time Frame
Baseline, Day 35, Month 3
Title
Conjunctival Hyperaemia in the Study Eye
Description
Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).
Time Frame
Baseline, Day 35, Month 3
Title
Study Product Use
Description
The number of times the study product is administered per day is recorded.
Time Frame
Day 8, Day 35, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Use of artificial tears for dry eye in both eyes for at least 3 months Use of preservative-free artificial tears at least twice daily for 2 weeks; Exclusion Criteria: Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months Use of punctal plugs or contact lenses in the last month Active ocular allergy within last 2 years Best corrected visual acuity (BCVA) less than 20/200 in either eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Paris
Country
France
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28452989
Citation
Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28. Erratum In: Eye (Lond). 2017 Oct;31(10 ):1512.
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A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye

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