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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05661851 | Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients | PHASE2 | COMPLETED | 121 | — | — | Feb 23, 2023 | Apr 27, 2023 | Apr 27, 2025 | 8 | United States |
Subjective ocular comfort was assessed at baseline, and at 30-day follow-up using a Visual Analogue Scale (VAS) with continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). The change from baseline ocular comfort score was calculated as 30-day follow-up score minus baseline score. Change from baseline VAS scores range from -100 to 100, where higher change from baseline comfort scores indicates better performance. The average change from baseline comfort score for each Arm was reported.
| Arm | Type | Description |
|---|---|---|
| Investigational product | EXPERIMENTAL | Eligible subjects will be randomly assigned the investigational product to be used in both eyes for the duration of the study. |
| Control product | ACTIVE_COMPARATOR | Eligible subjects will be randomly assigned the control product to be used in both eyes for the duration of the study |
| Name | Type | Description |
|---|---|---|
| Investigational Lubricating Eye Drop in a Novelia® bottle | DRUG | Investigational Product |
| Blink® Tears eye Drops | DRUG | Control Product |
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this c...