Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

Study Overview
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Brief Summary
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The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Detailed Description
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Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Official Title
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Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Other: Preservative-free saline solution eyedrops
* Other: Systane® ULTRA lubricant eyedrops
* Other: OPTIVE® lubricating eyedrops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to attend all study visits. Diagnosis of dry eye, as specified in protocol. Uses artificial tears, as specified in protocol. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Poor visual acuity, as specified in protocol. Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol. Any hypersensitivity or allergy to the investigational products or ingredients. Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol. Contact lens use within 2 weeks of Screening Visit. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Ultra<br>Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). | Other: Preservative-free saline solution eyedrops<br>* 1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.<br>Other: Systane® ULTRA lubricant eyedrops<br> <br> |
| Active Comparator: Optive<br>OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). | Other: Preservative-free saline solution eyedrops<br>* 1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.<br>Other: OPTIVE® lubricating eyedrops<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis. | Baseline, Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis. | Day 35 | 
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. | Day 35 | 
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. | Day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye syndrome, Systane Ultra, Optive, Ocular Surface Staining, OSDI, Eye drops