Optive Brand For Day And Night Dry Eye Management

NCT03208673 | Completed Results

• 1 other identifier: CMO-EAME-EYE-0485
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking

  Baseline (day 0) to (day 30 +/- 3 days)

Study Arms (1)

Optive® Fusion + Optive® Gel Drop

EXPERIMENTAL

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

Interventions

Optive® Fusion + Optive® Gel Drop 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.

Optive® Fusion + Optive® Gel Drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Ocular Technology Group - international

London, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Allergan

CTRegistration@allergan.com

714-246-4500

Study Officials

• Sameena Haque

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 5, 2017
• Study Start: July 3, 2017
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-03

Locations

GB (1)