Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Study Overview
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Brief Summary
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Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CL discomfort. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of patients who have CL discomfort.

Detailed Description
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Soft contact lenses (CL) are the most common CL modality with over 140 million users world. Despite many improvements in CL materials and solutions, the advent of daily disposable CLs, and the addition of rewetting drops to improve CL comfort, research has shown that between 21% to 64% of CL wearers permanently discontinue CL use because of eye discomfort. Contact Lens Discomfort (CLD) as defined by the Tear Film and Ocular Surface Society (TFOS) is a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the CL and the eye's environment, which can lead to decreased wearing time and discontinuation of CL wear. TFOS further states that CLD is a multifactorial condition that stems from both CL (e.g., material design, fit, care system) and environmental factors (patient factors, medication compliance, external environmental factors, ocular environment). While environmental factors related to the patient such as age and sex are inherent, rewetting drops or artificial tears can be used to treat tear film deficiencies associated with CLD. The U.S. Food & Drug Administration (FDA) defines rewetting/lubricating drops as an in-eye solution for use with CLs that contains one or more active ingredients (e.g., ophthalmic demulcents) in sufficient concentration to alleviate symptoms of discomfort from CL wear by physical means. Clinicians also commonly use artificial tears off label for treating CLD and the dry eye associated with CLs because artificial tear formulations have the potential to outperform CL rewetting drops. The FDA separately classifies artificial tears as topical drops that contain specific types of demulcents or emollients. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CLD. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the Research Goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of CLD suffers.

Official Title
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Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Conditions
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Contact Lens Discomfort, Dry Eye

Intervention / Treatment
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* Drug: Systane Complete


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported contact lens discomfort Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12 Daily disposable contact lens wearer Best-corrected visual acuity of 20/30 or better Exclusion Criteria: All other contact lens types (e.g., currently wearing two week or monthly replacement contact lenses or hard contact lenses) Non-compliant daily disposable contact lens wearers (must regularly replace contact lenses daily) Systemic health conditions known to alter tear film physiology History of ocular surgery within the past 12 months History of severe ocular trauma, active ocular infection, or inflammation Currently using Accutane or eye medications Pregnant or breast feeding

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
Interventional Model Description: One group will be randomized Systane Complete, and one group will be randomized to no treatment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Complete<br>Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use. | Drug: Systane Complete<br>* Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.<br>|
| No Intervention: No Treatment<br>Subjects randomized to this group will not receive a treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Symptoms | Improvement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being the best score. | Baseline through 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Day Eye Comfort | Improvement in eye symptoms as measured with the Standardized Patient Evaluation of Eye Dryness (SPEED) at 2 weeks compared to baseline. The scale range is 0 to 28 with 0 being the best score. | Baseline through 2 Weeks | 
| Corneal Staining | Improvement in conjuctivial staining at two weeks compared to baseline using the Brien Holden Vision Institute (BHVI) scale, which measures five regions of the eye on a (0-4) scale (max of 20 per metric). A score 0 is the best possible score. | Baseline through 2 Weeks | 
| Schirmer's I Test Without Anesthetic | Improvement in tear volume as measured in mm of wetting with a Schirmer's strip at 5 mins at 2 weeks compared to baseline. The score ranges is 0 mm to 35 mm with 35 mm being the best score. | Baseline through 2 Weeks | 
| Tear Break-Up Time (TBUT) | Improvement in tear break up time as measured with a slit-lamp biomicroscope and sodium fluorescein in seconds at 2 weeks compared to baseline. Scores range for 0 to 60 seconds with 60 seconds being the best score. | Baseline through 2 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Tears, Systane Complete, Contact Lens Discomfort, Dry Eye, Daily Disposable Contact Lenses