Optive Brand For Day And Night Dry Eye Management

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

Official Title
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Optive Brand For Day And Night Dry Eye Management

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Optive® Fusion + Optive® Gel Drop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optive® Fusion + Optive® Gel Drop<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Change from baseline to (day 30 +/- 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (day 0) to (day 30 +/- 3 days) |