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Refresh Optive

Phase 3

Dry Eye Syndromes | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Apr 16, 2019

Refresh Optive target and mechanism

ModalitySmall molecule

Also known as Refresh Optive® Gel Drops

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment188

FDA Designations

No designations recorded

Refresh Optive clinical trials

Refresh Optive · 1 trial · 1 indication

Phase 3 1
NCT02280473A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye DiseaseDry Eye Syndromes
COMPLETED188 Analytics
PHASE3COMPLETED
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
Dry Eye SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Baseline, Day 30

The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

Secondary Endpoints

Change From Baseline in the OSDI© Score
Baseline, Day 7
Change From Baseline in Tear Break-up Time (TBUT)
Baseline, Day 30
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Baseline, Day 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Refresh Optive® Gel DropsEXPERIMENTALRefresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
REFRESH LIQUIGEL®ACTIVE_COMPARATORREFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Interventions

NameTypeDescription
Refresh Optive® Gel DropsDRUGRefresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
REFRESH LIQUIGEL®DRUGREFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Current use of an artificial tear product * Visual acuity of at least 20/32 (while wearing glasses, if necessary). Exclusion Criteria: * Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * Cataract surgery, laser-assisted in si...

Countries:United States
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Frequently asked questions about Refresh Optive

What is Refresh Optive used for?

Refresh Optive is used for dry eye syndromes, a group of conditions in which the eyes do not produce enough tears or tears evaporate too quickly. It is an ophthalmology product developed by AbbVie Inc. under ticker ABBV. A Phase 3 study evaluated it in patients with dry eye disease.

Who makes Refresh Optive?

Refresh Optive is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company behind the Refresh Optive program in ophthalmology, and it sponsored the Phase 3 clinical study of Refresh Optive Gel Drops in patients with dry eye disease.

What phase is Refresh Optive in?

Refresh Optive is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, active-controlled trial that enrolled 188 patients with dry eye disease in the United States.

What clinical trials is Refresh Optive in?

Refresh Optive has been studied in one Phase 3 trial, NCT02280473, titled A Safety and Efficacy Study of Refresh Optive Gel Drops in Patients With Dry Eye Disease. It was a completed, randomized, double-blind, active-controlled study that enrolled 188 participants aged 18 years and older in the United States.

Is Refresh Optive the same as Refresh Optive Gel Drops?

Yes, Refresh Optive is also known as Refresh Optive Gel Drops. The alternative name appears with the registered trademark symbol as Refresh Optive® Gel Drops. Both names refer to the same AbbVie ophthalmology product studied in dry eye disease under the Phase 3 trial NCT02280473.