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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 eye
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 Eye is an investigational small molecule being developed for Dry Eye Syndromes. It is a lubricant eye drop formulation studied in patients with moderate to severe dry eye. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.
AbbVie Inc. (NYSE: ABBV) is developing Carboxymethylcellulose Based Eye. The company is conducting Phase 3 clinical trials for this investigational treatment for Dry Eye Syndromes. AbbVie is responsible for the drug's development and regulatory pathway.
Carboxymethylcellulose Based Eye is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total of 321 participants enrolled. The drug remains investigational and has not received FDA approval for Dry Eye Syndromes.
Carboxymethylcellulose Based Eye has completed two Phase 3 trials: NCT02455050, comparing the formulation with Systane Gel Drops and Genteal Lubricant Gel Drops in 79 patients, and NCT02553772, a safety and efficacy study in 242 patients with dry eye disease. Both trials are completed.
Carboxymethylcellulose Based Eye works as a lubricant for the eye surface, providing relief for dry eye symptoms. It is formulated with carboxymethylcellulose, a compound that helps retain moisture on the ocular surface. The drug is administered as eye drops to alleviate discomfort associated with Dry Eye Syndromes.