Back to resultsEfficacy and Safety Study of FID 119515A
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FID 119515A
Blink® Tears
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Tear film, Tear break-up time, Ocular surface, Eye drops
Eligibility Criteria
Inclusion Criteria:
- Sign Informed Consent.
- Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
- At least a 3 month documented history of dry eye in both eyes.
- TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Any evidence of ocular infection or inflammation within 30 days prior to Screening.
- Any ocular surgery.
- Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
- Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
- Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
- Participation in any other clinical trial within 30 days prior to Screening.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FID 119515A
Blink
Arm Description
FID 119515A, 1 drop instilled in the study eye, single dose
Blink® Tears, 1 drop instilled in the study eye, single dose
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
Secondary Outcome Measures
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01833117
Brief Title
Efficacy and Safety Study of FID 119515A
Official Title
A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
Detailed Description
Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye, Tear film, Tear break-up time, Ocular surface, Eye drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FID 119515A
Arm Type
Experimental
Arm Description
FID 119515A, 1 drop instilled in the study eye, single dose
Arm Title
Blink
Arm Type
Active Comparator
Arm Description
Blink® Tears, 1 drop instilled in the study eye, single dose
Intervention Type
Other
Intervention Name(s)
FID 119515A
Intervention Description
topical ocular drops
Intervention Type
Other
Intervention Name(s)
Blink® Tears
Intervention Description
topical ocular drops
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
Description
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
Time Frame
Baseline, 60 minutes
Secondary Outcome Measure Information:
Title
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes
Description
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
Time Frame
0 to 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign Informed Consent.
Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
At least a 3 month documented history of dry eye in both eyes.
TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Pregnant or breastfeeding.
Any evidence of ocular infection or inflammation within 30 days prior to Screening.
Any ocular surgery.
Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
Participation in any other clinical trial within 30 days prior to Screening.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Lindsey, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of FID 119515A
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