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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01159015 | Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers | PHASE3 | COMPLETED | 534 | — | — | Jul 1, 2010 | Oct 1, 2010 | Oct 5, 2020 | - | — |
An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
| Arm | Type | Description |
|---|---|---|
| KetoNaph | EXPERIMENTAL | KetoNaph Ophthalmic Solution |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of KetoNaph Ophthalmic Solution |
| Name | Type | Description |
|---|---|---|
| KetoNaph | DRUG | Ophthalmic Solution administered BID for 6 weeks |
| Vehicle | DRUG | Vehicle of KetoNaph ophthalmic solution administered bid for six weeks |
Inclusion Criteria: * Subjects less than 18 years of age, have either a history or family history of ocular allergy. * ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentall...