A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye (MELODY-1)
Primary Purpose
Dry Eye, Dry Eye Syndromes
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vehicle Opthalmic Solution
PL9643 Opthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Ophthalmology, Eye diseases, Corneal diseases, Conjunctival diseases, Ophthalmic Solutions, Pharmaceutical Solutions
Eligibility Criteria
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
Sites / Locations
- Palatin Clinical Site #9Recruiting
- Palatin Clinical Site #6Recruiting
- Palatin Clinical Site #7Recruiting
- Palatin Clinical Site #5Recruiting
- Palatin Clinical Site #1Recruiting
- Palatin Clinical Site #8Recruiting
- Palatin Clinical Site #4Recruiting
- Palatin Clinical Site #10Recruiting
- Palatin Clinical Site #2Recruiting
- Palatin Clinical Site #3Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PL9643 Opthalmic Solution
Vehicle Opthalmic Solution
Arm Description
PL9643 ophthalmic solution bilaterally three times a day.
Vehicle opthalmic solution bilaterally three times a day.
Outcomes
Primary Outcome Measures
Inferior Corneal Fluorescein Staining
Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale.
Ocular Discomfort
Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Conjunctival Sum Lissamine Green Staining
Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05201170
First Posted
January 8, 2022
Last Updated
January 20, 2022
Sponsor
Palatin Technologies, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05201170
Brief Title
A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye
Acronym
MELODY-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palatin Technologies, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes
Keywords
Dry eye, Ophthalmology, Eye diseases, Corneal diseases, Conjunctival diseases, Ophthalmic Solutions, Pharmaceutical Solutions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1 to either the PL9643 treatment group or to the control group.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PL9643 Opthalmic Solution
Arm Type
Experimental
Arm Description
PL9643 ophthalmic solution bilaterally three times a day.
Arm Title
Vehicle Opthalmic Solution
Arm Type
Active Comparator
Arm Description
Vehicle opthalmic solution bilaterally three times a day.
Intervention Type
Drug
Intervention Name(s)
Vehicle Opthalmic Solution
Other Intervention Name(s)
Control
Intervention Description
Opthalmic Solution
Intervention Type
Drug
Intervention Name(s)
PL9643 Opthalmic Solution
Other Intervention Name(s)
Active study medication
Intervention Description
Opthalmic Solution
Primary Outcome Measure Information:
Title
Inferior Corneal Fluorescein Staining
Description
Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale.
Time Frame
Change from Baseline Week 12 (Day 85)
Title
Ocular Discomfort
Description
Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Time Frame
Change from Baseline through Day 15 (Week 2)
Title
Conjunctival Sum Lissamine Green Staining
Description
Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale
Time Frame
Baseline and Week 12 (Day 85)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Winters
Phone
609-495-2243
Email
jwinters@palatin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Winters
Organizational Affiliation
Palatin
Official's Role
Study Director
Facility Information:
Facility Name
Palatin Clinical Site #9
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #6
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #7
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #5
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #1
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #8
City
Mint Hill
State/Province
North Carolina
ZIP/Postal Code
28227
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #4
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #10
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #2
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Palatin Clinical Site #3
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye
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