Optive Brand For Day And Night Dry Eye Management

Allergan

Status: Completed

Conditions: Dry Eye

Treatments: Device: Optive® Fusion + Optive® Gel Drop

Study type: Interventional

Funder types: Industry

Identifiers

NCT03208673

CMO-EAME-EYE-0485

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Optive® Fusion + Optive® Gel Drop

Experimental group

Description:

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.

Treatment:

Device: Optive® Fusion + Optive® Gel Drop