Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

Study Overview
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Brief Summary
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This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.

Official Title
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A Double-Masked, Randomized, Placebo-Controlled Study of Loteprednol Etabonate Ophthalmic Suspension, 0.5% for the Treatment of Dry Eye Used Either TID or QID for a 2 Week Period

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: loteprednol etabonate ophthalmic suspension, 0.5%
* Drug: loteprednol etabonate ophthalmic suspension, 0.5%
* Drug: vehicle of loteprednol etabonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age or older able and willing to follow instructions, including participation in study assessments and able be present for the required study visits for the duration of the study If female and of childbearing potential, were not pregnant, nursing, or planning a pregnancy. Women of childbearing potential were required to have a negative urine pregnancy test at the pre-screen visit and had to agree to use an acceptable method of mechanical or hormonal contraceptive for the duration of the study a diagnosis of dry eye a history of intermittent or regular artificial tear use within the past 3 months best corrected visual acuity (BCVA) of +0.7 or better assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in one or both eyes a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 OR a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 with a conjunctival redness score of ≥ 1.5+ at Visit 1 and before CAE exposure at Visits 2 and 3 in at least one eye Demonstrated a response when exposed to the CAE at Visits 2 and 3 Exclusion Criteria: clinically significant blepharitis or Meibomian Gland Dysfunction (MGD) or lid margin inflammation, particularly if systemic or topical medications were currently being used to treat any of these diagnoses diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis), or preauricular lymphadenopathy, particularly if systemic or topical medications were currently being used to treat any of these diagnoses Reported an ocular discomfort score of 4+ in both eyes at time 0 of CAE exposure at Visits 2 or 3 Wore contact lenses and refused to remove them for the duration of the study previous laser in situ keratomileusis (LASIK) surgery currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and could not discontinue these medications for the duration of the study presently taking any medication known to cause ocular drying that had not been a stable dose for at least 30 days currently taking oral antihistamines that could not be discontinued during the study a systemic disease, uncontrolled medical condition that in the opinion of the investigator could interfere with study measurements or subject compliance received another experimental drug or device within 30 days prior to screening

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: Loteprednol Etabonate TID<br>loteprednol etabonate ophthalmic suspension, 0.5%, TID | Drug: loteprednol etabonate ophthalmic suspension, 0.5%<br>* TID<br>* Other names: Lotemax;|
| Experimental: Loteprednol Etabonate QID<br>loteprednol etabonate ophthalmic suspension, 0.5%, QID | Drug: loteprednol etabonate ophthalmic suspension, 0.5%<br>* QID<br>* Other names: Lotemax;|
| Placebo Comparator: Vehicle<br>vehicle of loteprednol etabonate | Drug: vehicle of loteprednol etabonate<br>* TID or BID according to the randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular discomfort during CAE exposure |  | during CAE exposure | 
| Corneal and conjunctival staining and conjunctival redness |  | After CAE exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal and conjunctival staining and conjunctival redness |  | before CAE exposure | 
| Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI) |  | before after CAE exposure | 
| Ocular discomfort |  | collected in patient diaries |