Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-03-23

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.

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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.

Conditions

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Contact Lens Discomfort Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will be randomized Systane Complete, and one group will be randomized to no treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The patients who are randomized to Systane Complete will be masked to the brand of the artificial tears.

There will be a masked examiner who does not know the subject's study group.

Study Groups

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Systane Complete

Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.

Group Type EXPERIMENTAL

Systane Complete

Intervention Type DRUG

Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.

No Treatment

Subjects randomized to this group will not receive a treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Systane Complete

Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No