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Carboxymethylcellulose 0.5%

Phase 4

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

Carboxymethylcellulose 0.5% development status

Highest phase Phase 4 (NCT00987727)
Phase scored for ABBVPhase 2/3
Registered trials 1 across 1 sponsor since Oct 2009

Carboxymethylcellulose 0.5% target and mechanism

Also known as Carboxymethylcellulose Sodium 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 0.5% clinical trials

Carboxymethylcellulose 0.5% · 2 trials · 2 indications

Phase 2/3 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
PHASE2/PHASE3COMPLETED
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
AmetropiaUnlock trial analytics
PHASE2/PHASE3COMPLETED
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 0.5%

What is carboxymethylcellulose and glycerin used for?

Carboxymethylcellulose and glycerin is an investigational lubricant eye drop being studied for dry eye and for rewetting during contact lens wear in people with ametropia. It is being developed by AbbVie Inc. (ticker ABBV) and has been tested in completed Phase 2/3 clinical trials.

Who makes carboxymethylcellulose and glycerin eye drops?

AbbVie Inc., which trades under the ticker ABBV, is the developer of the carboxymethylcellulose and glycerin lubricant eye drop. The program has been evaluated in two completed Phase 2/3 studies conducted in the United States, one in dry eye and one in contact lens wearers with ametropia.

What phase is carboxymethylcellulose and glycerin in?

Carboxymethylcellulose and glycerin is in Phase 2/3 development. Both of its recorded trials, NCT00691197 and NCT00243711, are listed as completed, and no trials are currently active. It is an investigational lubricant eye drop and is not described as an approved product.

What clinical trials is carboxymethylcellulose and glycerin in?

Two completed Phase 2/3 trials have studied carboxymethylcellulose and glycerin. NCT00243711 was a multicenter randomized study of an investigational lubricant eye drop in dry eye, enrolling 286 adults. NCT00691197 evaluated safety and acceptability of a rewetting drop with contact lens wear in 246 healthy adult volunteers with ametropia.

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

Yes. Carboxymethylcellulose and glycerin is also known as carboxymethylcellulose sodium 0.5%, carboxymethylcellulose 0.5%, and carboxymethylcellulose sodium and glycerin. These names refer to the same AbbVie lubricant eye drop formulation studied in dry eye and contact lens rewetting.

How were the carboxymethylcellulose and glycerin trials designed?

Both trials were randomized, double-blind, and active-controlled Phase 2/3 studies in adults aged 18 and older, with participants of all sexes. NCT00243711 enrolled 286 people with dry eye, while NCT00691197 enrolled 246 healthy contact lens wearers with ametropia. Neither study used biomarker-based patient selection.