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Also known as carboxymethylcellulose sodium based new eye drop formulation, Carboxymethylcellulose Based Eye Drop, Carboxymethylcellulose Based Eye, Carboxymethylcellulose Sodium Based Eye Drops, carboxymethylcellulose based New Eye Formulation 1, carboxymethylcellulose sodium based eye drop solution
carboxymethylcellulose based new eye formulation · 4 trials · 2 indications
The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).
The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
| Arm | Type | Description |
|---|---|---|
| OM3 Tear | EXPERIMENTAL | Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| REFRESH OPTIVE® ADVANCED | ACTIVE_COMPARATOR | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| New Eye Drop Formulation then Systane® | OTHER | 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks. |
| Systane® then New Eye Drop Formulation | OTHER | 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. |
| Genteal® then New Eye Drop Formulation | OTHER | 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. |
| New Eye Drop Formulation then Genteal® | OTHER | 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks. |
| New Eye Drop Formulation | EXPERIMENTAL | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. |
| REFRESH PLUS® | ACTIVE_COMPARATOR | 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. |
| New Eye Drop Formulation 1 | EXPERIMENTAL | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. |
| New Eye Drop Formulation 2 | EXPERIMENTAL | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. |
| Refresh Tears® | ACTIVE_COMPARATOR | 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days. |
| Name | Type | Description |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop | DRUG | Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| Carboxymethylcellulose Sodium 0.5% | DRUG | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| Carboxymethylcellulose Sodium Based Eye Drops | DRUG | 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye. |
| Systane® Gel Drops | DRUG | 1 to 2 drops of Systane® Gel Drops in each eye. |
| Genteal® Lubricant Gel Drops | DRUG | 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye. |
| carboxymethylcellulose sodium based new eye drop formulation | DRUG | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. |
| carboxymethylcellulose sodium based New Eye Drop Formulation 1 | DRUG | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. |
| carboxymethylcellulose sodium based New Eye Drop Formulation 2 | DRUG | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. |
Inclusion Criteria: * Used artificial tears for dry eye * Visual acuity of at least 20/32 (while wearing glasses, if necessary). Exclusion Criteria: * Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * Herpes keratitis in the last 6 months * Catara...
Carboxymethylcellulose based new eye formulation is an investigational eye drop developed by AbbVie Inc. (ABBV) for dry eye syndromes and for use following bilateral LASIK surgery. It is a small molecule formulation studied in Phase 3 clinical trials. It is designed as an eye drop solution for ocular surface relief.
Carboxymethylcellulose based new eye formulation is being studied for two indications: dry eye syndromes and bilateral LASIK surgery. The dry eye trials enrolled adults with moderate to severe dry eye, while the LASIK trial evaluated participants following refractive surgery. All studies were Phase 3 and have been completed.
AbbVie Inc., which trades under the ticker ABBV, is the developer of carboxymethylcellulose based new eye formulation. The company sponsored all three completed Phase 3 trials of the eye drop, which were conducted across the United States, Australia, and Canada.
Carboxymethylcellulose based new eye formulation has been studied in Phase 3 clinical development. Three Phase 3 trials have been completed, with no active trials currently listed. It is an investigational formulation and is not described as approved.
Three completed Phase 3 trials have evaluated carboxymethylcellulose based new eye formulation: NCT02553772 in dry eye disease with 242 participants, NCT02455050 comparing it with Systane Gel Drops and Genteal Lubricant Gel Drops with 79 participants, and NCT01886690 following LASIK surgery with 148 participants. A fourth study, NCT01294384, compared formulations with Refresh Tears in 305 dry eye patients.
Yes. Carboxymethylcellulose based new eye formulation is also known as carboxymethylcellulose sodium based eye drop formulation, carboxymethylcellulose based eye drop, carboxymethylcellulose sodium based eye drops, and carboxymethylcellulose based eye. These names refer to the same AbbVie investigational eye drop studied in Phase 3 trials for dry eye and post-LASIK use.