A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye
Public ClinicalTrials.gov record NCT05201170. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-center, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of the Melanocortin, PL9643 Ophthalmic Solution, Compared to Vehicle in Subjects with Dry Eye
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05201170
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 575 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 30, 2021 (Actual)
- Primary completion
- Sep 1, 2023 (Actual)
- Completion
- Nov 21, 2023 (Actual)
- Last update posted
- Oct 17, 2024
2021 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Global Research Management | Glendale | California | 91204 | — |
| Eye Research Foundation | Newport Beach | California | 92663 | — |
| East West Eye Institute | Torrance | California | 90505 | — |
| Pankratz Eye Institute | Columbus | Indiana | 47203 | — |
| Michael Washburn Center for Ophthalmic Research, LLC | Indianapolis | Indiana | 46240 | — |
| Kentucky Eye Institute | Lexington | Kentucky | 40517 | — |
| Butchertown Clinical Trials | Louisville | Kentucky | 40206 | — |
| Andover Eye Associates | Andover | Massachusetts | 01810 | — |
| Center for Sight | Las Vegas | Nevada | 89052 | — |
| Mint Hill | Mint Hill | North Carolina | 28227 | — |
| Core, Inc | Shelby | North Carolina | 28150 | — |
| Bergstrom Eye research, LLC | Fargo | North Dakota | 58103 | — |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | — |
| Advancing Vision Research | Goodlettsville | Tennessee | 37072 | — |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | — |
| Advancing Vision Research | Smyrna | Tennessee | 37167 | — |
| Austin Clinical Research | Austin | Texas | 78750 | — |
| Axis Clinical | Dallas | Texas | 75243 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05201170, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 17, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05201170 live on ClinicalTrials.gov.