Optive Brand For Day And Night Dry Eye Management

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Optive® Fusion + Optive® Gel Drop

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW1E 6AU
    • Ocular Technology Group - International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Sameena Haque, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): September 6, 2017
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CMO-EAME-EYE-0485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No