Optive Brand For Day And Night Dry Eye Management | NCT03208673 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 20, 2019
Optive Brand For Day And Night Dry Eye Management
Optive Brand For Day And Night Dry Eye Management
ClinicalTrials.gov ID
NCT03208673
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
35Actual
Last Update Posted
Jun 20, 2019Actual
Start Date
Jul 3, 2017Actual
Primary Completion Date
Sep 6, 2017Actual
Completion Date
Sep 6, 2017Actual
Official Title
Optive Brand For Day And Night Dry Eye Management
Brief Summary
This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
Dry Eye
Optive® Fusion + Optive® Gel Drop
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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