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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06803654 | A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness | PHASE3 | COMPLETED | 578 | — | — | May 22, 2025 | Jun 29, 2025 | May 28, 2026 | 11 | United States |
Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes
| Arm | Type | Description |
|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) | EXPERIMENTAL | - |
| Brimonidine tartrate ophthalmic solution 0.025% | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BTOS-HA | DRUG | Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart |
| Lumify® | DRUG | Brimonidine tartrate ophthalmic solution 0.025%, administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart |
Inclusion Criteria: 1. Voluntarily provide written informed consent 2. ≥18 years of age 3. Able and willing to follow instructions, including participation in all trial assessments and visits 4. History of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use over ...