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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03334539 | A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes | PHASE2 | COMPLETED | 150 | — | — | Nov 5, 2017 | Apr 9, 2018 | Mar 7, 2024 | 2 | United States |
It was evaluated for the inferior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
It is assessed by the Ora Calibra® Ocular Discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe) with 1 point increments, where lower scores indicate improvement.
| Arm | Type | Description |
|---|---|---|
| 0.10% HL036 Ophthalmic Solution | EXPERIMENTAL | Participants self-administered HL036 0.10 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. |
| 0.25% HL036 Ophthalmic Solution | EXPERIMENTAL | Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| Placebo | PLACEBO_COMPARATOR | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| Name | Type | Description |
|---|---|---|
| HL036 ophthalmic solution | BIOLOGICAL | HL036 ophthalmic solution |
| Placebo vehicle solution | OTHER | Placebo vehicle solution |
Inclusion Criteria: * Have a patient-reported history of dry eye for at least 6 months prior to enrollment * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 * Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2 Excl...