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NCT05201170 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye
A Phase 3 study, sponsored by Palatin Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 575
- Enrollment target
NCT05201170 is a Phase 3 study that has completed, run by Palatin Technologies. The registered enrollment target is 575 participants.
The verdict
NCT05201170, a Phase 3 study, has completed, sponsored by Palatin Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 575 participants
- Enrollment target
Study 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.
Interventions
- DRUG Vehicle Ophthalmic Solution
- DRUG PL9643 Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2021-12-30 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05201170
The ClinicalTrials.gov registry entry for NCT05201170 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Palatin Technologies, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle Ophthalmic Solution is the first listed.
NCT05201170 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05201170 about?
NCT05201170 is a clinical study titled "A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye". 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 sol...
What is the current status of trial NCT05201170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2021-12-30. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT05201170?
The interventions under investigation include: Vehicle Ophthalmic Solution (DRUG), PL9643 Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT05201170?
This trial is sponsored by Palatin Technologies, which has 9 total clinical trials registered on ClinicalTrials.gov.
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