Dry Eye Clinical Trial - A Phase 3, Multi-Center Study Evaluating PL9643

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms