Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03682809

Enrollment

Registered

2018-09-25

Start date

2018-11-19

Completion date

2019-03-23

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Lens Discomfort, Dry Eye

Keywords

Artificial Tears, Systane Complete, Contact Lens Discomfort, Dry Eye, Daily Disposable Contact Lenses

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.

Interventions

DRUGSystane Complete

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Contact Lens Symptoms	Baseline through 2 Weeks	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.

Secondary

Measure	Time frame	Description
End of Day Eye Comfort	Baseline through 2 Weeks	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.
Corneal Staining	Baseline through 2 Weeks	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.
Schirmer's I Test Without Anesthetic	Baseline through 2 Weeks	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.
Tear Break-Up Time (TBUT)	Baseline through 2 Weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Systane Complete Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use. Systane Complete: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.	22
No Treatment Subjects randomized to this group will not receive a treatment.	24
Total	46

Baseline characteristics

Characteristic	No Treatment	Total	Systane Complete
Age, Continuous	28.8 Years	30.75 Years	32.7 Years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	24 participants	46 participants	22 participants
Sex: Female, Male Female	19 Participants	39 Participants	20 Participants
Sex: Female, Male Male	5 Participants	7 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 24
other Total, other adverse events	0 / 22	0 / 24
serious Total, serious adverse events	0 / 22	0 / 24

Outcome results

Primary

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.