NCT05201170

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

A Phase 3, Multi-center, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of the Melanocortin, PL9643 Ophthalmic Solution, Compared to Vehicle in Subjects with Dry Eye

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 575 (actual)
• Sponsor: Palatin Technologies, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic 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 ophthalmic solution or vehicle ophthalmic solution administered bilaterally three times a day for 12 weeks. A Data Monitoring Committee was engaged to review interim data.

Detailed description

This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution, to determine the safety and efficacy against a vehicle 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 in a 1:1 ratio 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.

Conditions

• Dry Eye
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Vehicle Ophthalmic Solution	Ophthalmic Solution
DRUG	PL9643 Ophthalmic Solution	Ophthalmic Solution

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-09-01
• Completion: 2023-11-21
• First posted: 2022-01-21
• Last updated: 2024-10-17

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study