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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palatin Technologies, Inc
• Treatments: Pharmaceutical Solutions

Criteria

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