Optive Brand For Day And Night Dry Eye Management

NCT ID: NCT03208673

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2017-09-06

Brief Summary

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

Conditions

Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Optive® Fusion + Optive® Gel Drop

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sameena Haque

Role: STUDY_DIRECTOR

Allergan

Locations

Ocular Technology Group - international

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CMO-EAME-EYE-0485

Identifier Type: -

Identifier Source: org_study_id