Clinical trial NCT03682809: Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
Official title: Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contact Lens Discomfort
Dry Eye
Keywords: Artificial Tears
Systane Complete
Contact Lens Discomfort
Dry Eye
Daily Disposable Contact Lenses
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Southern College of Optometry
name: Lindenhurst Eye Physicians & Surgeons, PC
name: Alcon Research
First posted: 2018-09-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be randomized Systane Complete, and one group will be randomized to no treatment.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contact Lens Symptoms
timeFrame: Baseline through 2 Weeks
Secondary outcomes:
measure: End of Day Eye Comfort
timeFrame: Baseline through 2 Weeks
measure: Corneal Staining
timeFrame: Baseline through 2 Weeks
measure: Schirmer's I Test Without Anesthetic
timeFrame: Baseline through 2 Weeks
measure: Tear Break-Up Time (TBUT)
timeFrame: Baseline through 2 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Babylon
country: United States
facility: Lindenhurst Eye Physicians & Surgeons, P.C.
state: New York
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
Study officials:
References:
citation: McDonald M, Schachet JL, Lievens CW, Kern JR. Systane(R) ultra lubricant eye drops for treatment of contact lens-related dryness. Eye Contact Lens. 2014 Mar;40(2):106-10. doi: 10.1097/ICL.0000000000000018.