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Refresh Optive

Phase 3

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

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

Clinical trial landscape

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. It is an investigational small molecule being developed by AbbVie Inc. for the treatment of dry eye disease. The drug is currently in Phase 3 clinical development, though the specific trial for this asset has been completed.

Who makes Refresh Optive?

Refresh Optive is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is being studied for the treatment of dry eye syndromes, a condition within the ophthalmology therapeutic area.

What phase is Refresh Optive in?

Refresh Optive is in Phase 3 clinical development. The drug is being investigated for the treatment of dry eye syndromes. While the Phase 3 trial has been completed, Refresh Optive remains an investigational drug and has not been approved for commercial use.

What clinical trials is Refresh Optive in?

Refresh Optive has been studied in a Phase 3 clinical trial identified as NCT02280473. This trial, titled "A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease," was conducted in the United States and enrolled 188 participants. The study was completed and was randomized, double-blind, and active-controlled.

Is Refresh Optive the same as Refresh Optive Gel Drops?

Yes, Refresh Optive is the same as Refresh Optive Gel Drops. The Phase 3 clinical trial NCT02280473 specifically evaluated Refresh Optive Gel Drops in patients with dry eye disease. The drug is being developed by AbbVie Inc. for the treatment of dry eye syndromes.