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carboxymethylcellulose based eye formula

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment365

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Carboxymethylcellulose based eye formula is used for contact lens lubrication in patients with contact lens-related discomfort. It is an investigational small molecule being developed by AbbVie Inc. (ABBV) for the ophthalmology therapeutic area. The drug is currently in Phase 3 clinical development.

What does carboxymethylcellulose based eye formula target?

Carboxymethylcellulose based eye formula is a lubricating eye drop that works by providing moisture and lubrication to the eye surface, which helps reduce friction and discomfort associated with contact lens wear. It does not target a specific molecular receptor but acts as a physical lubricant.

Who makes carboxymethylcellulose based eye formula?

Carboxymethylcellulose based eye formula is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 3 clinical trials for contact lens lubrication.

What phase is carboxymethylcellulose based eye formula in?

Carboxymethylcellulose based eye formula is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its safety and efficacy for contact lens lubrication.

What clinical trials is carboxymethylcellulose based eye formula in?

Carboxymethylcellulose based eye formula has one completed Phase 3 clinical trial, NCT01844388, which compared the 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 Refresh Contacts?

Carboxymethylcellulose based eye formula is not the same as Refresh Contacts. It is a new eye drop formulation being compared against Refresh Contacts® in a clinical trial. Refresh Contacts is an existing product used as an active control in the study, while the carboxymethylcellulose based eye formula is the investigational drug.