MELODY-1: A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye

Sponsor

Palatin Technologies, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05201170

Collaborator

(none)

240

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized 1:1 to either the PL9643 treatment group or to the control group.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.

Primary Purpose:

Treatment

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 :

Dec 30, 2021

Anticipated Primary Completion Date :

Sep 29, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PL9643 Opthalmic Solution PL9643 ophthalmic solution bilaterally three times a day.	Drug: PL9643 Opthalmic Solution Opthalmic Solution Other Names: Active study medication
Active Comparator: Vehicle Opthalmic Solution Vehicle opthalmic solution bilaterally three times a day.	Drug: Vehicle Opthalmic Solution Opthalmic Solution Other Names: Control

Arm

Intervention/Treatment

Experimental: PL9643 Opthalmic Solution

PL9643 ophthalmic solution bilaterally three times a day.

Drug: PL9643 Opthalmic Solution

Opthalmic Solution

Other Names:

Active study medication

Active Comparator: Vehicle Opthalmic Solution

Vehicle opthalmic solution bilaterally three times a day.

Drug: Vehicle Opthalmic Solution

Opthalmic Solution

Other Names:

Control

Outcome Measures

Primary Outcome Measures

Inferior Corneal Fluorescein Staining [Change from Baseline Week 12 (Day 85)]
Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale.
Ocular Discomfort [Change from Baseline through Day 15 (Week 2)]
Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Conjunctival Sum Lissamine Green Staining [Baseline and Week 12 (Day 85)]
Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be at least 18 years of age
Provide written informed consent
Be willing and able to comply with all study procedures
Have a patient-reported history of dry eye
Have a history of use or desire to use eye drops for dry eye symptoms
Have a best corrected visual acuity (BCVA) of 0.7

Exclusion Criteria:

Have any clinically significant slit-lamp findings
Be diagnosed with an ongoing ocular infection
Have worn contact lenses within 7 days of Visit 1
Have used Restasis®, Xiidra®, Cequa®, or Eysuvis®
Have had any ocular and/or lid surgeries
Be currently taking any topical ophthalmic prescription
Have an uncontrolled systemic disease
Be a woman who is pregnant, nursing, or planning a pregnancy;
Be a woman of childbearing potential who is not using an acceptable means of birth control
Participated in a previous clinical study involving PL9643
Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palatin Clinical Site #9	Newport Beach	California	United States	92663
2	Palatin Clinical Site #6	Carmel	Indiana	United States	46290
3	Palatin Clinical Site #7	Lexington	Kentucky	United States	40517
4	Palatin Clinical Site #5	Lewiston	Maine	United States	04240
5	Palatin Clinical Site #1	Andover	Massachusetts	United States	01810
6	Palatin Clinical Site #8	Mint Hill	North Carolina	United States	28227
7	Palatin Clinical Site #4	Shelby	North Carolina	United States	28150
8	Palatin Clinical Site #10	Wilmington	North Carolina	United States	28411
9	Palatin Clinical Site #2	Memphis	Tennessee	United States	38119
10	Palatin Clinical Site #3	Smyrna	Tennessee	United States	37167