Optive Brand For Day And Night Dry Eye Management

Not Applicable

Completed

Brief Summary: This is an open label study of Optive eyedrops and gel combination for day and night dry eye management

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Optive® Fusion + Optive® Gel Drop	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.

Primary Outcome Measures

Name	Time	Method
Measured Lissamine Green Bulbar Conjunctival Staining (mm2)	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 Ocular Surface Disease Index (OSDI) Total Score	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking	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.