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Optive Brand For Day And Night Dry Eye Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208673
Recruitment Status : Completed
First Posted : July 5, 2017
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Dry Eye Device: Optive® Fusion + Optive® Gel Drop Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optive Brand For Day And Night Dry Eye Management
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : September 6, 2017
Actual Study Completion Date : September 6, 2017

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.




Primary Outcome Measures :
  1. Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score [ Time Frame: Change from baseline to (day 30 +/- 3 days) ]
    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.

  2. Measured Lissamine Green Bulbar Conjunctival Staining (mm2) [ Time Frame: Change from baseline to (day 30 +/- 3 days) ]
    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).


Secondary Outcome Measures :
  1. Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking [ Time Frame: Baseline (day 0) to (day 30 +/- 3 days) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208673


Locations
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United Kingdom
Ocular Technology Group - international
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Sameena Haque Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] May 18, 2017
Statistical Analysis Plan  [PDF] December 5, 2017


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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03208673    
Other Study ID Numbers: CMO-EAME-EYE-0485
First Posted: July 5, 2017    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases