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0.02% Betamethasone

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Harrow, Inc.|Last Updated: Jun 4, 2025

Target and mechanism

ModalitySmall molecule

Also known as 0.02% Betamethasone Sodium Phosphate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

0.02% Betamethasone · 1 trial · 1 indication

Phase 2 1
NCT04734210Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye DiseaseDry Eye Disease
COMPLETED139 Analytics
PHASE2COMPLETED
Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease
Dry Eye DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
Baseline and Day 8

The UNC DEMS scale is a participant-specific 10-point scale with a minimum score of 1 (\[1-2\] My symptoms are not a problem. My dry eye does not affect my daily life at all) and a maximum score of 10 (\[9-10\] my symptoms are severe and I need immediate medical care. My dry eye greatly affects my daily life). Participants with a minimum reduction of ≥1 point in UNC DEMS score from baseline were defined as responders, and response rates were summarized by treatment group.

Secondary Endpoints

University of North Carolina Dry Eye Management Scale (UNC DEMS) Responder Analysis
Baseline and Day 15
Conjunctival Hyperemia Responder Analysis
Baseline and Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SURF-200 (0.02% betamethasone sodium phosphate in vehicle)EXPERIMENTALOne drop twice daily (BID) in the study eye for 14 days.
SURF-200 (0.04% betamethasone sodium phosphate in vehicle)EXPERIMENTALOne drop BID in the study eye for 14 days.
VehiclePLACEBO_COMPARATOROne drop BID in the study eye for 14 days.

Interventions

NameTypeDescription
0.02% Betamethasone Sodium PhosphateDRUGtopical corticosteroid solution
0.04% Betamethasone Sodium PhosphateDRUGtopical corticosteroid solution
PlaceboDRUGtopical vehicle solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1. Subjects 18 years of age and older who have a diagnosis of dry eye disease and experiencing an episodic flare up. Criteria for the diagnosis must include the following: 1. UNC DEMS score of greater than or equal to 5 but less than or equal to 9 2. Conjunctival hyperemi...

Countries:United States
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Competitive Landscape -Dry Eye Disease 6 trials

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Frequently asked questions about 0.02% Betamethasone

What is 0.02% Betamethasone used for?

0.02% Betamethasone is being studied for the treatment of dry eye disease, specifically for patients experiencing an episodic flare-up of the condition. It is an investigational ophthalmic eye drop formulation. The research focuses on adults 18 years and older with dry eye disease in the United States.

Who is developing 0.02% Betamethasone?

0.02% Betamethasone is being developed by Harrow, Inc., which trades under the ticker symbol HROW. The company is advancing this ophthalmic small molecule formulation as a potential treatment for dry eye disease.

What phase is 0.02% Betamethasone in?

0.02% Betamethasone is in Phase 2 clinical development. The completed Phase 2 trial evaluated the eye drop in patients with dry eye disease. It is an investigational therapy and has not been approved by the FDA for any indication.

What clinical trials is 0.02% Betamethasone in?

0.02% Betamethasone has been studied in one completed Phase 2 clinical trial, NCT04734210. The trial was a randomized, double-blind, placebo-controlled study that enrolled 139 participants with dry eye disease in the United States. It assessed the eye drop compared with vehicle in subjects experiencing an episodic flare-up.

Is 0.02% Betamethasone the same as 0.02% Betamethasone Sodium Phosphate?

Yes, 0.02% Betamethasone is also known as 0.02% Betamethasone Sodium Phosphate. The two names refer to the same ophthalmic formulation being developed by Harrow, Inc. for dry eye disease.