This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Ocular Technology Group - international
London, United Kingdom
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.
Time frame: Change from baseline to (day 30 +/- 3 days)
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).
Time frame: Change from baseline to (day 30 +/- 3 days)
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.
Time frame: Baseline (day 0) to (day 30 +/- 3 days)
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