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Carboxymethylcellulose and Glycerin

Phase 2

Ametropia | Unknown | Ophthalmology |AbbVie Inc.|Trials Updated: Jul 22, 2015

Carboxymethylcellulose and Glycerin target and mechanism

ModalityUnknown

Also known as Carboxymethylcellulose Sodium 0.5%, Carboxymethylcellulose 0.5%

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment532

FDA Designations

No designations recorded

Carboxymethylcellulose and Glycerin clinical trials

Carboxymethylcellulose and Glycerin · 2 trials · 2 indications

Phase 2 2
NCT00691197Safety and Acceptability of Using a Rewetting Drop With Contact Lens WearAmetropia
COMPLETED246 Analytics
NCT00243711A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye DropDry Eye
COMPLETED286 Analytics
PHASE2COMPLETED
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
AmetropiaUnlock trial analytics
PHASE2COMPLETED
A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop
Dry EyeUnlock trial analytics

Study Endpoints

Primary Endpoints

Best Corrected Visual Acuity
Change from Baseline at Day 90

Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.

Dry Eye Symptoms

Secondary Endpoints

Corneal Staining
Day 90
Ocular surface damage, tear stability, tear production
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Carboxymethylcellulose sodium and GlycerinEXPERIMENTALCarboxymethylcellulose sodium and Glycerin based rewetting drop
Carboxymethylcellulose sodiumACTIVE_COMPARATORCarboxymethylcellulose sodium based rewetting drop

Interventions

NameTypeDescription
Carboxymethylcellulose sodium and GlycerinDEVICEEye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Carboxymethylcellulose sodiumDEVICEEye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adapted contact lens wearer Exclusion Criteria: * Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

Countries:United States
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Frequently asked questions about Carboxymethylcellulose and Glycerin

What is carboxymethylcellulose and glycerin used for?

Carboxymethylcellulose and glycerin is an investigational lubricant eye drop being studied for dry eye and for rewetting contact lenses in people with ametropia. It is designed as a topical ophthalmic drop. Both studied uses are in Phase 2 clinical development, and the product is not described as approved for marketing.

Who is developing carboxymethylcellulose and glycerin?

AbbVie Inc. (ticker ABBV) is the developer of carboxymethylcellulose and glycerin. The company has sponsored the clinical program evaluating this lubricant eye drop formulation in ophthalmology indications, including dry eye and contact lens rewetting. No other developer or partner is identified for this asset.

What phase is carboxymethylcellulose and glycerin in?

Carboxymethylcellulose and glycerin is in Phase 2 clinical development. Two Phase 2 studies have been completed, one in dry eye and one in ametropia, and no active trials are currently listed. The asset remains investigational and has not been described as FDA approved.

What clinical trials is carboxymethylcellulose and glycerin in?

Two completed Phase 2 trials have evaluated carboxymethylcellulose and glycerin. NCT00691197 studied safety and acceptability of a rewetting drop with contact lens wear in 246 participants with ametropia. NCT00243711 was a multi-center randomized study of an investigational lubricant eye drop in 286 participants with dry eye. Both were conducted in the United States.

Is carboxymethylcellulose and glycerin the same as carboxymethylcellulose sodium 0.5%?

Yes. Carboxymethylcellulose and glycerin is also known as carboxymethylcellulose sodium and glycerin, carboxymethylcellulose sodium 0.5%, and carboxymethylcellulose 0.5%. These names refer to the same investigational ophthalmic lubricant formulation developed by AbbVie Inc. for dry eye and contact lens rewetting.

How were the carboxymethylcellulose and glycerin trials designed?

The Phase 2 program for carboxymethylcellulose and glycerin used randomized, double-blind, active-controlled designs. NCT00243711 enrolled 286 participants with dry eye, and NCT00691197 enrolled 246 contact lens wearers with ametropia, including healthy volunteers. Both studies required participants to be at least 18 years old and enrolled all sexes.