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Carboxymethylcellulose Based Lubricant Eye

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 Enrollment315

FDA Designations

No designations recorded

Clinical trial landscape

Carboxymethylcellulose Based Lubricant Eye · 1 trial · 1 indication

Phase 3 1
NCT01459588Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye DiseaseDry Eye Syndromes
COMPLETED315 Analytics
PHASE3COMPLETED
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Dry Eye SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
Baseline, Day 30

The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.

Secondary Endpoints

Change From Baseline in Tear Break-up Time
Baseline, Day 30
Change From Baseline in Corneal Staining
Baseline, Day 30
Change From Baseline in Conjunctival Staining
Baseline, Day 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Carboxymethylcellulose Based Eye Drop Formulation AEXPERIMENTALCarboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Based Eye Drop Formulation BEXPERIMENTALCarboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Preservative-Free Lubricant Eye DropsACTIVE_COMPARATORCarboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Lubricant Eye DropsACTIVE_COMPARATORCarboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Interventions

NameTypeDescription
Carboxymethylcellulose Based Eye Drop Formulation ADRUGCarboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Based Eye Drop Formulation BDRUGCarboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsDRUGCarboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Lubricant Eye DropsDRUGCarboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 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 Sites1

Inclusion Criteria: * Dry eyes * Current use of eye drops for dry eye at least twice daily, on average for at least 3 months Exclusion Criteria: * Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months * Need to wear contact len...

Countries:United States
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Frequently asked questions about Carboxymethylcellulose Based Lubricant Eye

What is Carboxymethylcellulose Based Lubricant Eye used for?

Carboxymethylcellulose Based Lubricant Eye is used for dry eye syndromes. It is an ophthalmology product being developed as a small molecule. The drug is intended to provide lubrication for the eye in patients with dry eye disease.

Who makes Carboxymethylcellulose Based Lubricant Eye?

Carboxymethylcellulose Based Lubricant Eye is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical research on this lubricant eye drop formulation for the treatment of dry eye syndromes.

What phase is Carboxymethylcellulose Based Lubricant Eye in?

Carboxymethylcellulose Based Lubricant Eye is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation for dry eye syndromes.

What clinical trials is Carboxymethylcellulose Based Lubricant Eye in?

Carboxymethylcellulose Based Lubricant Eye has one completed Phase 3 clinical trial, NCT01459588, titled "Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease." The trial enrolled 315 participants in the United States and included adults aged 18 years and older.

Is Carboxymethylcellulose Based Lubricant Eye a randomized controlled trial?

Yes, the Phase 3 clinical trial for Carboxymethylcellulose Based Lubricant Eye was randomized, double-blind, and active-controlled. The study compared the eye drop formulation against an active control in patients with dry eye disease, and it enrolled 315 participants.