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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01844388 | A Study to Compare a New Eye Drop Formulation With Refresh Contacts® | PHASE3 | COMPLETED | 365 | — | — | May 29, 2013 | Dec 2, 2013 | Apr 16, 2019 | 1 | United States |
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
| Arm | Type | Description |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formula | EXPERIMENTAL | 1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. |
| REFRESH CONTACTS® | ACTIVE_COMPARATOR | 1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. |
| Name | Type | Description |
|---|---|---|
| carboxymethylcellulose based eye drop formula | DRUG | 1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. |
| carboxymethylcellulose sodium based eye drop solution | DRUG | 1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. |
Inclusion Criteria: -Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week. Exclusion Criteria: * Wearing monovision lenses * Have had refractive surgery within the previous 12 months * Have infection of the eye, eyelids or eye structures.