5201170
Last Update Posted: 2024-10-17
Recruiting has ended
All Genders accepted | 18 Years + |
575 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye
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.
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.
Eligibility
Relevant conditions:
Dry Eye
Dry Eye Syndromes
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
Jason Winters
jwinters@palatin.com
609-495-2243
Data sourced from ClinicalTrials.gov