Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.

Detailed Description
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This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.

Official Title
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Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Propylene Glycol, 0.6% eye drops
* Drug: Preservative-free 0.9% Saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have all of the following in at least 1 eye at Screening: Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2, The average of 3 measures of TFBUT ≤ 5 seconds, and Unanesthetized Schirmer I test of ≥ 3 mm. Must have an Ocular Surface Disease Index (OSDI) Score ≥ 18 at Visit 1 prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day). Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart (letter read method). Physician diagnosis of dry eye at least 6 months prior to Screening visit. Willing and able to attend all study visits. Must sign a written informed consent form. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening. Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening. Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening. Women of childbearing potential are excluded from participating in this study if they met any of the following conditions: Currently pregnant, or Test positive for pregnancy at Screening visit, or Currently breast feeding, or Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products. Has an active ocular allergy. Any ocular abnormalities that could adversely affect the safety or efficacy outcome, including eyelid anomalies, corneal disorders, history of herpes simplex, etc. Subjects taking any systemic medication known to cause dry eye unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study. History of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants, or serious ocular trauma within 1 year of Screening. Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc. Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening. Any significant illnesses that could be expected to interfere with the study parameters. Subjects with active oculodermal rosacea with meibomian gland dysfunction. Participation in an investigational drug or device trial within 30 days of Screening. Contact lens use within 30 days prior to Screening, or unwilling to avoid contact lens use during the course of the study. Unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study. Other protocol-defined exclusion criteria may apply.

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: Systane Balance<br>Propylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). | Drug: Propylene Glycol, 0.6% eye drops<br>* Commercially available eye drops used during Treatment Phase<br>* Other names: Systane® Balance;|
| Active Comparator: Saline<br>Preservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). | Drug: Preservative-free 0.9% Saline solution<br>* Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in TFBUT at Day 35 | TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in TOSS Score at Day 35 | The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 35 | 
| Change From Baseline in OSDI Score at Day 35 | The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health. | Baseline (Day 0), Day 35 | 
| Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35 | The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement. | Baseline (Day 0), Day 35 | 
| Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35 | The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement. | Baseline (Day 0), Day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipid deficiency, Tear film break-up time, Dry eye