A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye (MELODY-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05201170|
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : January 31, 2022
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an opthalmic 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 opthalmic solution or vehicle opthalmic solution administered bilaterally three times a day for 12 weeks.
A Data Monitoring Committee will be engaged to review interim data.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Dry Eye Syndromes||Drug: Vehicle Opthalmic Solution Drug: PL9643 Opthalmic Solution||Phase 3|
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an opthalmic solution, to determine the safety and efficacy against a comparator in dry eye patients.
During a 2-week/14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Vehicle Ophthalmic Solution (vehicle) bilaterally three times a day. Randomization will then occur as 1:1 where patients will be assigned to receive PL9643 ophthalmic solution given bilaterally three times a day or vehicle ophthalmic solution administered bilaterally three times a day. The treatment period is 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized 1:1 to either the PL9643 treatment group or to the control group.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All individuals involved in the conduct of the study, and the enrolled patients, will remain blinded to the randomized study treatment assignments until the database is unblinded.|
|Official Title:||This is a Multi-center, Double-masked, Randomized, Vehicle-controlled Study Testing PL9643, an Opthalmic Solution, to Determine if it is Safe and Efficacious for Dry Eye Patients|
|Actual Study Start Date :||December 30, 2021|
|Estimated Primary Completion Date :||September 29, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: PL9643 Opthalmic Solution
PL9643 ophthalmic solution bilaterally three times a day.
Drug: PL9643 Opthalmic Solution
Other Name: Active study medication
Active Comparator: Vehicle Opthalmic Solution
Vehicle opthalmic solution bilaterally three times a day.
Drug: Vehicle Opthalmic Solution
Other Name: Control
- Inferior Corneal Fluorescein Staining [ Time Frame: Change from Baseline Week 12 (Day 85) ]Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale.
- Ocular Discomfort [ Time Frame: Change from Baseline through Day 15 (Week 2) ]Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
- Conjunctival Sum Lissamine Green Staining [ Time Frame: Baseline and Week 12 (Day 85) ]Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05201170
|Contact: Jason Wintersfirstname.lastname@example.org|
|United States, California|
|Palatin Clinical Site #9||Recruiting|
|Newport Beach, California, United States, 92663|
|United States, Indiana|
|Palatin Clinical Site #6||Recruiting|
|Carmel, Indiana, United States, 46290|
|United States, Kentucky|
|Palatin Clinical Site #7||Recruiting|
|Lexington, Kentucky, United States, 40517|
|United States, Maine|
|Palatin Clinical Site #5||Recruiting|
|Lewiston, Maine, United States, 04240|
|United States, Massachusetts|
|Palatin Clinical Site #1||Recruiting|
|Andover, Massachusetts, United States, 01810|
|United States, North Carolina|
|Palatin Clinical Site #8||Recruiting|
|Mint Hill, North Carolina, United States, 28227|
|Palatin Clinical Site #4||Recruiting|
|Shelby, North Carolina, United States, 28150|
|Palatin Clinical Site #10||Recruiting|
|Wilmington, North Carolina, United States, 28411|
|United States, Tennessee|
|Palatin Clinical Site #2||Recruiting|
|Memphis, Tennessee, United States, 38119|
|Palatin Clinical Site #3||Recruiting|
|Smyrna, Tennessee, United States, 37167|
|Study Director:||Jason Winters||Palatin|