Back to resultsOptive Brand For Day And Night Dry Eye Management
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optive® Fusion + Optive® Gel Drop
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- OSDI score of ≥ 23
- Ocular comfort at waking <65 on 100-point scale
- Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
- Use of eyedrops for the relief of dry eye symptoms for at least one month
- Best corrected visual acuity in each eye of at least 20/25
- Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
- Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion Criteria:
- Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
- Use of Optive brand eyedrops in the last month
- Monocular participants (only one eye with functional vision).
- Contact lens wear during the study
- History of herpetic keratitis, ocular surgery or irregular cornea;
- Known pregnancy or lactation during the study period
- Participation in any clinical trial within 30 days of the enrollment visit
Sites / Locations
- Ocular Technology Group - international
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optive® Fusion + Optive® Gel Drop
Arm Description
Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. The treatment regimen will be used for one month.
Outcomes
Primary Outcome Measures
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Measured Lissamine Green Bulbar Conjunctival Staining (mm2)
The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).
Secondary Outcome Measures
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking
The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03208673
Brief Title
Optive Brand For Day And Night Dry Eye Management
Official Title
Optive Brand For Day And Night Dry Eye Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
September 6, 2017 (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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optive® Fusion + Optive® Gel Drop
Arm Type
Experimental
Arm Description
Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. The treatment regimen will be used for one month.
Intervention Type
Device
Intervention Name(s)
Optive® Fusion + Optive® Gel Drop
Intervention Description
Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Primary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Description
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Time Frame
Change from baseline to (day 30 +/- 3 days)
Title
Measured Lissamine Green Bulbar Conjunctival Staining (mm2)
Description
The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).
Time Frame
Change from baseline to (day 30 +/- 3 days)
Secondary Outcome Measure Information:
Title
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking
Description
The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms.
Time Frame
Baseline (day 0) to (day 30 +/- 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OSDI score of ≥ 23
Ocular comfort at waking <65 on 100-point scale
Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
Use of eyedrops for the relief of dry eye symptoms for at least one month
Best corrected visual acuity in each eye of at least 20/25
Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion Criteria:
Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
Use of Optive brand eyedrops in the last month
Monocular participants (only one eye with functional vision).
Contact lens wear during the study
History of herpetic keratitis, ocular surgery or irregular cornea;
Known pregnancy or lactation during the study period
Participation in any clinical trial within 30 days of the enrollment visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameena Haque
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Ocular Technology Group - international
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Optive Brand For Day And Night Dry Eye Management
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