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

Dry Eye Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

• NCT number: NCT05201170
• Study type: Interventional
• Source: Palatin Technologies, Inc
• Contact: Jason Winters
• Phone: 609-495-2243
• Email: [email protected]
• Status: Recruiting
• Phase: Phase 3
• Start date: December 30, 2021
• Completion date: December 31, 2022