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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01459588 | Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease | PHASE3 | COMPLETED | 315 | — | — | Oct 1, 2011 | Feb 15, 2012 | Apr 16, 2019 | 1 | United States |
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | EXPERIMENTAL | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Eye Drop Formulation B | EXPERIMENTAL | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | ACTIVE_COMPARATOR | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Lubricant Eye Drops | ACTIVE_COMPARATOR | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Name | Type | Description |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | DRUG | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Eye Drop Formulation B | DRUG | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops | DRUG | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Lubricant Eye Drops | DRUG | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
Inclusion Criteria: * Dry eyes * Current use of eye drops for dry eye at least twice daily, on average for at least 3 months Exclusion Criteria: * Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months * Need to wear contact len...