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

Dry Eye Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201170
• Other study ID #: PL9643-301
• Status: Recruiting
• Phase: Phase 3
• Start date: December 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Palatin Technologies, Inc
• Contact: Jason Winters
• Phone: 609-495-2243
• Email: jwinters[@]palatin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Vehicle Opthalmic Solution
Opthalmic Solution
• PL9643 Opthalmic Solution
Opthalmic Solution

Locations

Country	Name	City	State
United States	Palatin Clinical Site #1	Andover	Massachusetts
United States	Palatin Clinical Site #6	Carmel	Indiana
United States	Palatin Clinical Site #5	Lewiston	Maine
United States	Palatin Clinical Site #7	Lexington	Kentucky
United States	Palatin Clinical Site #2	Memphis	Tennessee
United States	Palatin Clinical Site #8	Mint Hill	North Carolina
United States	Palatin Clinical Site #9	Newport Beach	California
United States	Palatin Clinical Site #4	Shelby	North Carolina
United States	Palatin Clinical Site #3	Smyrna	Tennessee
United States	Palatin Clinical Site #10	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Palatin Technologies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inferior Corneal Fluorescein Staining	Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale.	Change from Baseline Week 12 (Day 85)
Primary	Ocular Discomfort	Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire	Change from Baseline through Day 15 (Week 2)
Primary	Conjunctival Sum Lissamine Green Staining	Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale	Baseline and Week 12 (Day 85)