Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Palatin Technologies.
NCT05201170 is a Phase 3 study that has completed, run by Palatin Technologies. The registered enrollment target is 575 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured by the Ora Calibra® Scale. Change from Baseline to week 12.
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 |
What the finished NCT05201170 record still lists
NCT05201170 is an interventional study that assigns participants to a tested intervention. The registered 575 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Ophthalmic Solution is the first listed.
NCT05201170 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05201170's enrollment target sits among peer trials
575 661st of 2000 higher than 1,338 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02610439 · 575 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
- NCT05919264 · 575 participants · Phase 1
FOG-001 in Locally Advanced or Metastatic Solid Tumors
- NCT06583148 · 575 participants · NA
A Smoke-Free Home Intervention in Tribal Communities
- NCT06883175 · 575 participants · NA
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI