Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03682809
• Collaborator: Southern College of Optometry (Other), Lindenhurst Eye Physicians & Surgeons, PC (Other), Alcon Research (Industry)
• Enrollment: 46
• Locations: 3
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site: 15.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Discomfort; Dry Eye	Drug: Systane Complete	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One group will be randomized Systane Complete, and one group will be randomized to no treatment.One group will be randomized Systane Complete, and one group will be randomized to no treatment.
• Masking: Double (Participant, 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.
• Primary Purpose: Treatment
• Official Title: Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
• Actual Study Start Date: Nov 19, 2018
• Actual Primary Completion Date: Mar 23, 2019
• Actual Study Completion Date: Mar 23, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Lindenhurst Eye Physicians & Surgeons, P.C.	Babylon	New York	United States	11702
3	Southern College of Optometry	Memphis	Tennessee	United States	38104

Sponsors and Collaborators

• University of Alabama at Birmingham
• Southern College of Optometry
• Lindenhurst Eye Physicians & Surgeons, PC
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 4, 2020

More Information

Publications

• McDonald M, Schachet JL, Lievens CW, Kern JR. Systane® 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.

• Responsible Party: Andrew Pucker, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03682809
• Other Study ID Numbers: 000522017
• First Posted: Sep 25, 2018
• Last Update Posted: Apr 6, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Andrew Pucker, Assistant Professor, University of Alabama at Birmingham: Artificial Tears; Systane Complete; Contact Lens Discomfort; Dry Eye; Daily Disposable Contact Lenses
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Arm/Group Title	Systane Complete	No Treatment
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.
Period Title: Overall Study
STARTED	22	24
COMPLETED	22	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Systane Complete	No Treatment	Total
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.	Total of all reporting groups
Overall Participants	22	24	46
Age (Years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [Years]	32.7	28.8	30.75
Sex: Female, Male (Count of Participants)
Female	20 90.9%	19 79.2%	39 84.8%
Male	2 9.1%	5 20.8%	7 15.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	22 100%	24 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Contact Lens Symptoms
Description	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.
Time Frame	Baseline through 2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Complete	No Treatment
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.
Measure Participants	22	24
Baseline cldeq-8 (worse eye)	20.41 (5.40)	18.92 (4.92)
2 week cldeq-8 (worse eye)	12.86 (6.40)	17.92 (5.30)
Baseline cldeq-4 (worse eye)	10.91 (3.28)	10.38 (2.41)
2 week cldeq-4 (worse eye)	7.14 (3.50)	10.13 (2.83)

2. Secondary Outcome

Title	End of Day Eye Comfort
Description	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.
Time Frame	Baseline through 2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Complete	No Treatment
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.
Measure Participants	22	24
Speed Score Baseline (worse eye)	10.27 (3.60)	9.67 (3.93)
Speed Score 2 weeks (worse eye)	7.55 (4.31)	9.29 (4.14)

3. Secondary Outcome

Title	Corneal Staining
Description	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.
Time Frame	Baseline through 2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Complete	No Treatment
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.
Measure Participants	22	24
Corneal Staining Extent (baseline)	1.73 (2.45)	1.63 (2.50)
Corneal Staining Depth (baseline)	1.22 (1.54)	0.92 (1.32)
Corneal Staining Type (baseline)	1.18 (1.56)	0.92 (1.32)
Corneal Staining Extent (2 weeks)	1.41 (2.42)	1.75 (1.98)
Corneal Staining Depth (2 weeks)	0.91 (1.38)	1.04 (1.30)
Corneal Staining Type (2 weeks)	0.86 (1.36)	0.92 (1.06)

4. Secondary Outcome

Title	Schirmer's I Test Without Anesthetic
Description	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.
Time Frame	Baseline through 2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Complete	No Treatment
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.
Measure Participants	22	24
Schirmers Strip Baseline	15.68 (9.70)	20.88 (10.65)
Schirmers Strip (2 weeks)	15.41 (9.29)	18.30 (10.69)

5. Secondary Outcome

Title	Tear Break-Up Time (TBUT)
Description	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.
Time Frame	Baseline through 2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Systane Complete	No Treatment
Arm/Group Description	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.	Subjects randomized to this group will not receive a treatment.
Measure Participants	22	24
Tear Break Up Time (seconds) (baseline)	7.70 (5.20)	8.50 (5.10)
Tear Break Up Time (seconds) (2 weeks)	8.57 (4.73)	8.80 (5.08)

Adverse Events

Time Frame	Data was collected 14-17 days after the baseline visit.
Adverse Event Reporting Description	There were no adverse events in this study
Arm/Group Title	Systane Complete		No Treatment
Arm/Group Description	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.		Subjects randomized to this group will not receive a treatment.
All Cause Mortality
	Systane Complete		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/24 (0%)
Serious Adverse Events
	Systane Complete		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Systane Complete		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/24 (0%)

Limitations/Caveats

The results presented in this record have no known limitations or caveats.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.