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Artificial Tears REFRESH ENDURA

Phase 2

Dry Eye Syndromes | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Dec 20, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

Artificial Tears REFRESH ENDURA · 1 trial · 1 indication

Phase 2 1
NCT00611403Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK PatientsDry Eye Syndromes
COMPLETED137 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Dry Eye SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Patients With Clinical Success at Month 6
Month 6

Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.

Secondary Endpoints

Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
Baseline, Month 6
Change From Baseline in Goblet Cell Density of the Eyes at Month 6
Baseline, Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RESTASIS®ACTIVE_COMPARATORCyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®ACTIVE_COMPARATORArtificial Tears (REFRESH ENDURA®)

Interventions

NameTypeDescription
Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)DRUGCyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
Artificial Tears REFRESH ENDURA®DRUGREFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
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Eligibility Criteria

Age Range21 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient is scheduled for bilateral LASIK surgery * Patient is in good general health * Eye glasses prescription of -1 to -8 Exclusion Criteria: * Significant Dry Eye * Presence of eye disease * Uncontrolled systemic disease

Countries:United States
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Frequently asked questions about Artificial Tears REFRESH ENDURA

What is Artificial Tears REFRESH ENDURA used for?

Artificial Tears REFRESH ENDURA is used for Dry Eye Syndromes. It is an investigational small molecule being developed by AbbVie Inc. for the treatment of dry eye conditions. The drug is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities.

Who makes Artificial Tears REFRESH ENDURA?

AbbVie Inc. (NYSE: ABBV) is the developer of Artificial Tears REFRESH ENDURA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for Dry Eye Syndromes. As of the latest data, the drug is in Phase 2 development.

What phase is Artificial Tears REFRESH ENDURA in?

Artificial Tears REFRESH ENDURA is in Phase 2 clinical development. It is an investigational drug for Dry Eye Syndromes and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug remains under investigation for its safety and efficacy.

What clinical trials is Artificial Tears REFRESH ENDURA in?

Artificial Tears REFRESH ENDURA has one completed clinical trial, NCT00611403, titled "Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients." This Phase 2 study enrolled 137 participants with Dry Eye Syndromes in the United States. The trial was randomized, double-blind, and active-controlled.

Is Artificial Tears REFRESH ENDURA the same as cyclosporine ophthalmic emulsion?

Yes, Artificial Tears REFRESH ENDURA is associated with cyclosporine ophthalmic emulsion, as indicated by the clinical trial NCT00611403, which evaluated this treatment. The trial specifically studied the safety and efficacy of cyclosporine ophthalmic emulsion in post-LASIK patients with Dry Eye Syndromes.