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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dry Eye, Dry Eye Syndromes

Intervention / Treatment
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* Drug: Vehicle Opthalmic Solution
* Drug: PL9643 Opthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Provide written informed consent Be willing and able to comply with all study procedures Have a patient-reported history of dry eye Have a history of use or desire to use eye drops for dry eye symptoms Have a best corrected visual acuity (BCVA) of 0.7 Exclusion Criteria: Have any clinically significant slit-lamp findings Be diagnosed with an ongoing ocular infection Have worn contact lenses within 7 days of Visit 1 Have used Restasis®, Xiidra®, Cequa®, or Eysuvis® Have had any ocular and/or lid surgeries Be currently taking any topical ophthalmic prescription Have an uncontrolled systemic disease Be a woman who is pregnant, nursing, or planning a pregnancy; Be a woman of childbearing potential who is not using an acceptable means of birth control Participated in a previous clinical study involving PL9643 Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1 to either the PL9643 treatment group or to the control group.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL9643 Opthalmic Solution<br>PL9643 ophthalmic solution bilaterally three times a day. | Drug: PL9643 Opthalmic Solution<br>* Opthalmic Solution<br>* Other names: Active study medication;|
| Active Comparator: Vehicle Opthalmic Solution<br>Vehicle opthalmic solution bilaterally three times a day. | Drug: Vehicle Opthalmic Solution<br>* Opthalmic Solution<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior Corneal Fluorescein Staining | Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale. | Change from Baseline Week 12 (Day 85) | 
| Ocular Discomfort | Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire | Change from Baseline through Day 15 (Week 2) | 
| Conjunctival Sum Lissamine Green Staining | Measured by the Ora Calibra® Corneal and Conjunctival Staining Scale | Baseline and Week 12 (Day 85) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Ophthalmology, Eye diseases, Corneal diseases, Conjunctival diseases, Ophthalmic Solutions, Pharmaceutical Solutions