A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye
Summary
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution to determine if safe and efficacious for dry eye patients. After a 2-week run-in period, patients will be randomized equally to the PL9643 ophthalmic solution or vehicle ophthalmic solution administered bilaterally three times a day for 12 weeks. A Data Monitoring Committee was engaged to review interim data.
Timeline
- Start
- 2021-12-30
- Primary completion
- 2023-09-01
- Completion
- 2023-11-21
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
release “On an Intent-to-Treat Analysis, Co-Primary Symptom Endpoint Met , Statistical Significance (P<0.025)” reads as mixed primary results palatin.com ↗
release “On an Intent-to-Treat Analysis, Co-Primary Sign Endpoint and Secondary Sign Endpoints Not Met” reads as mixed primary results palatin.com ↗
release “Positive Phase 3 PL9643 MELODY-1 Pivotal Study Results Co-Primary Symptom Endpoint of Pain Met Statistical Significance (P<0.025)” reads as met primary endpoint palatin.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PL9643 | Unknown | — | Other |