Optive Brand For Day And Night Dry Eye Management
|ClinicalTrials.gov Identifier: NCT03208673|
Recruitment Status : Completed
First Posted : July 5, 2017
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Device: Optive® Fusion + Optive® Gel Drop||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optive Brand For Day And Night Dry Eye Management|
|Actual Study Start Date :||July 3, 2017|
|Actual Primary Completion Date :||September 6, 2017|
|Actual Study Completion Date :||September 6, 2017|
Experimental: Optive® Fusion + Optive® Gel Drop
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.
Device: Optive® Fusion + Optive® Gel Drop
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.
- Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score [ Time Frame: Change from baseline to (day 30 +/- 3 days) ]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) [ Time Frame: Change from baseline to (day 30 +/- 3 days) ]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).
- Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking [ Time Frame: Baseline (day 0) to (day 30 +/- 3 days) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208673
|Ocular Technology Group - international|
|London, United Kingdom, SW1E 6AU|
|Study Director:||Sameena Haque||Allergan|