Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

Study Overview
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Brief Summary
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Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

Detailed Description
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The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study. During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.

Official Title
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A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: PL9643 Ophthalmic Solution
* Drug: Placebo Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age. Provided written informed consent. Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye symptoms Have corrected visual acuity greater than or equal to +0.7 in both eyes Exclusion Criteria: Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) Have any planned ocular and/or lid surgeries over the study period. 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 Have a known allergy and/or sensitivity to the test article or its components. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study Have used an investigational drug or device within 30 days of Visit 1 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Ophthalmic Solution (vehicle)<br>vehicle | Drug: Placebo Ophthalmic Solution<br>* Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.<br>|
| Active Comparator: PL9643 Ophthalmic Solution<br>PL9643 Ophthalmic Solution | Drug: PL9643 Ophthalmic Solution<br>* PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale | An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE) | Day 85 | 
| Ocular Discomfort Using The Ora Calibra Scale | A patient-reported subjective assessment of ocular discomfort using the 0 [none] to 4 [worst] Ora Calibra Scale recorded at each study visit throughout the treatment period | Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Fluorescein Staining Using The Ora Calibra Scale | An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE) | 12 weeks | 
| Conjunctival Lissamine Green Staining Using The Ora Calibra Scale | An assessment of conjunctival lissamine green staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE) | 12 weeks | 
| Conjunctival Redness Using The Ora Calibra Scale | An assessment of conjunctival redness using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE) | 12 weeks |