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Trial record 1 of 1 for:    PL9643-301
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A Phase 3, Multi-Center Study Evaluating PL9643 in Patients With Dry Eye (MELODY-1)

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ClinicalTrials.gov Identifier: NCT05201170
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies, Inc

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : December 30, 2021
Estimated Primary Completion Date : September 29, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: PL9643 Opthalmic Solution
PL9643 ophthalmic solution bilaterally three times a day.
 Drug: PL9643 Opthalmic Solution
Opthalmic Solution
Other Name: Active study medication
Active Comparator: Vehicle Opthalmic Solution
Vehicle opthalmic solution bilaterally three times a day.
 Drug: Vehicle Opthalmic Solution
Opthalmic Solution
Other Name: Control


Outcome Measures
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Primary Outcome Measures :
  1. Inferior Corneal Fluorescein Staining [ Time Frame: Change from Baseline Week 12 (Day 85) ]
    Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale.

  2. Ocular Discomfort [ Time Frame: Change from Baseline through Day 15 (Week 2) ]
    Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire

  3. Conjunctival Sum Lissamine Green Staining [ Time Frame: Baseline and Week 12 (Day 85) ]
    Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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


Contacts
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Contact: Jason Winters 609-495-2243 jwinters@palatin.com

Locations
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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
Sponsors and Collaborators
Palatin Technologies, Inc
Investigators
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Study Director: Jason Winters Palatin
More Information
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Responsible Party: Palatin Technologies, Inc
ClinicalTrials.gov Identifier: NCT05201170    
Other Study ID Numbers: PL9643-301
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palatin Technologies, Inc:
Dry eye
Ophthalmology
Eye diseases
Corneal diseases
 Conjunctival diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions