Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02553772 | A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease. | PHASE3 | COMPLETED | 242 | — | — | Jan 6, 2016 | Sep 9, 2016 | Nov 17, 2017 | 13 | United States, Australia |
| NCT02455050 | A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief | PHASE3 | COMPLETED | 79 | — | — | Dec 1, 2014 | Aug 1, 2015 | Jan 4, 2017 | 1 | United States |
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...