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Carboxymethylcellulose Based Eye · 2 trials · 1 indication
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).
| 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. |
| 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. |
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...
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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.