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carboxymethylcellulose based eye formula

Phase 3

Contact Lens Lubrication | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Apr 16, 2019

carboxymethylcellulose based eye formula target and mechanism

ModalitySmall molecule

Also known as carboxymethylcellulose based eye drop formula

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment365

FDA Designations

No designations recorded

carboxymethylcellulose based eye formula clinical trials

carboxymethylcellulose based eye formula · 1 trial · 1 indication

Phase 3 1
NCT01844388A Study to Compare a New Eye Drop Formulation With Refresh Contacts®Contact Lens Lubrication
COMPLETED365 Analytics
PHASE3COMPLETED
A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
Contact Lens LubricationUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Baseline, Day 90

Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Carboxymethylcellulose Based Eye Drop FormulaEXPERIMENTAL1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
REFRESH CONTACTS®ACTIVE_COMPARATOR1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.

Interventions

NameTypeDescription
carboxymethylcellulose based eye drop formulaDRUG1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
carboxymethylcellulose sodium based eye drop solutionDRUG1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
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Eligibility Criteria

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

Inclusion Criteria: -Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week. Exclusion Criteria: * Wearing monovision lenses * Have had refractive surgery within the previous 12 months * Have infection of the eye, eyelids or eye structures.

Countries:United States
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Frequently asked questions about carboxymethylcellulose based eye formula

What is carboxymethylcellulose based eye formula?

Carboxymethylcellulose based eye formula is an investigational small molecule eye drop developed by AbbVie Inc. (ticker: ABBV) for contact lens lubrication. It is designed to lubricate the eye while contact lenses are worn. The formula is in Phase 3 clinical development and has been studied in a completed trial.

What is carboxymethylcellulose based eye formula used for?

Carboxymethylcellulose based eye formula is used for contact lens lubrication. It is intended to provide lubrication for contact lens wearers. The indication studied in its clinical trial was contact lens lubrication, and the trial enrolled 365 participants.

Who makes carboxymethylcellulose based eye formula?

AbbVie Inc. (ticker: ABBV) makes carboxymethylcellulose based eye formula. AbbVie is the developer of this investigational eye drop. The company is responsible for its clinical development.

What phase is carboxymethylcellulose based eye formula in?

Carboxymethylcellulose based eye formula is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. One Phase 3 trial has been completed, and no active trials are currently listed.

What clinical trials is carboxymethylcellulose based eye formula in?

Carboxymethylcellulose based eye formula has been studied in one completed Phase 3 trial, NCT01844388, titled A Study to Compare a New Eye Drop Formulation With Refresh Contacts. The trial enrolled 365 participants in the United States and was randomized, double-blind, and active-controlled.

Is carboxymethylcellulose based eye formula the same as carboxymethylcellulose based eye drop formula?

Yes, carboxymethylcellulose based eye formula is also known as carboxymethylcellulose based eye drop formula. Both names refer to the same investigational eye drop developed by AbbVie Inc. for contact lens lubrication.