Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

Study Overview
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Brief Summary
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The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Official Title
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A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: 0.3% BOL-303242-X ophthalmic suspension
* Drug: 2% BOL-303242-X ophthalmic suspension
* Drug: Placebo Comparator: Vehicle
* Drug: 1% BOL-303242-X ophthalmic suspension
* Drug: 2% BOL-303242-X ophthalmic suspension AM
* Drug: 2% BOL-303242-X ophthalmic suspension PM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have a diagnosis of dry eye disease. Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications. Subjects who are willing and able to refrain from using contact lenses during the study. Exclusion Criteria: Subjects with known hypersensitivity or contraindication to any component of the study medication. Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter). Subjects who are expected to require treatment with corticosteroids during the study. Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit. Subjects who have undergone any type of ocular surgery within three months prior to screening. Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit. Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3% BOL-303242-X ophthalmic suspension<br>0.3% BOL-303242-X ophthalmic suspension | Drug: 0.3% BOL-303242-X ophthalmic suspension<br>* 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.<br>|
| Experimental: 2% BOL-303242-X ophthalmic suspension<br>2% BOL-303242-X ophthalmic suspension | Drug: 2% BOL-303242-X ophthalmic suspension<br>* 2% BOL-303242-X ophthalmic suspension BID for 12 weeks.<br>|
| Placebo Comparator: Vehicle<br>Vehicle twice daily (BID) | Drug: Placebo Comparator: Vehicle<br>* Placebo Comparator: Vehicle BID for 12 weeks.<br>|
| Experimental: 1% BOL-303242-X ophthalmic suspension<br>1% BOL-303242-X ophthalmic suspension | Drug: 1% BOL-303242-X ophthalmic suspension<br>* 1% BOL-303242-X ophthalmic suspension BID for 12 weeks.<br>|
| Experimental: 2% BOL-303242-X ophthalmic suspension in the morning<br>2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) | Drug: 2% BOL-303242-X ophthalmic suspension AM<br>* 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.<br>|
| Experimental: 2% BOL-303242-X ophthalmic suspension PM<br>Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. | Drug: 2% BOL-303242-X ophthalmic suspension PM<br>* Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Corneal Staining Score | Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome. | 12 weeks | 
| Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10. | 12 weeks |