Direct Application of Systane Complete to Contact Lenses

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03848221
• Collaborator: Alcon Research (Industry)
• Enrollment: 73
• Locations: 3
• Arms: 3
• Actual Duration (Months): 4.8
• Patients Per Site: 24.3
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food & Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye; Contact Lens Complication	Drug: Systane Complete; Drug: Sensitive Eyes Rewetting Drops	Phase 4

Detailed Description

Soft contact lenses are the ideal vision correction choice for many patients because soft contact lenses allow patients to have better and less restricted vision, they allow for an increased ability to perform work tasks and play sports, and they provide patients with a better perceived cosmetic appearance compared to spectacle lenses. While millions of people worldwide benefit from contact lenses, many of these patients experience contact lens discomfort, which limits their wear time and in many instances eventually result in discontinuation of contact lens use. In fact, 21% to 64% of contact lens wearers permanently discontinue contact lens use because of ocular discomfort. Contact lens discomfort is currently defined as "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 contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear." Although contact lens discomfort may stem from the lens itself, a situation that can be corrected by such means as switching to an alternative material or wear schedule, contact lens discomfort more typically occurs from ocular surface disease.

A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lens use. While rewetting drops and artificial tears are regulated under different U.S. Food & Drug Administration policies, artificial tears are not specifically indicated for use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops (e.g., some artificial tears have lipid supplements that have the potential to restore the external tear lipid layer). The safe and effective use of artificial tears with contact lenses is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduce dryness symptoms in contact lens wearers. However, the community currently lacks a rigorous scientific study aimed at understanding the utility of lipid-containing artificial tear (or rewetting drop) for alleviating contact lens discomfort while patients are wearing their contact lenses. Systane Complete, a new formulation of artificial tears, combines elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (lipid-containing artificial tear indicated for evaporative dry eye). Thus, the purpose of this study is to test the safety of Systane Complete and its ability to alleviate contact lens discomfort during the day while subjects are wearing their contact lenses. This goal will be accomplished by randomizing subjects to either Systane Complete, a commercially available rewetting drop, or no treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Investigator Masked, Randomized, Clinical TrialInvestigator Masked, Randomized, Clinical Trial
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The investigator will be masked to the subject's treatment. The subjects cannot be fully masked because there is a no treatment control group.
• Primary Purpose: Treatment
• Official Title: Direct Application of Systane Complete to Contact Lenses for the Treatment of Contact Lens Discomfort
• Actual Study Start Date: May 28, 2019
• Actual Primary Completion Date: Oct 20, 2019
• Actual Study Completion Date: Oct 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Complete Subjects in this group will use Systane Complete before, during, and after contact lens use.	Drug: Systane Complete; Systane Complete is an artificial tear.
Active Comparator: Sensitive Eyes Rewetting Drops Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.	Drug: Sensitive Eyes Rewetting Drops; Sensitive Eyes Rewetting Drops is a rewetting drop.
No Intervention: No Treatment Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.

Outcome Measures

Primary Outcome Measures

1. Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks [2 Weeks]

   The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.

Secondary Outcome Measures

1. Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline. [2 Weeks]

   The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Daily disposable contact lens wearers

• 20/30 visual acuity or better

• Self-report contact lens discomfort

• Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

Exclusion Criteria:

• Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)

• Non-compliant daily disposable contact lens wearers

• Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)

• History of ocular surgery within the past 12 months

• History of severe ocular trauma

• History of active ocular infection or inflammation

• Isotretinoin-derivatives use

• Ocular medication use

• Pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
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
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Oct 22, 2019

More Information

Publications

None provided.

• Responsible Party: Andrew Pucker, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03848221
• Other Study ID Numbers: 000523741
• First Posted: Feb 20, 2019
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 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: Systane Complete; Dry Eye; Contact Lens Discomfort; Artificial Tears; Rewetting Drops
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Arm/Group Title	Systane Complete	Sensitive Eyes Rewetting Drops	No Treatment
Arm/Group Description	Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
Period Title: Overall Study
STARTED	25	24	24
COMPLETED	25	24	24
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Systane Complete	Sensitive Eyes Rewetting Drops	No Treatment	Total
Arm/Group Description	Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.	Total of all reporting groups
Overall Participants	25	24	24	73
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	24 100%	24 100%	73 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	21 84%	19 79.2%	20 83.3%	60 82.2%
Male	4 16%	5 20.8%	4 16.7%	13 17.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	24 100%	24 100%	73 100%

Outcome Measures

1. Primary Outcome

Title	Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks
Description	The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers.

Arm/Group Title	Systane Complete	Sensitive Eyes Rewetting Drops	No Treatment
Arm/Group Description	Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
Measure Participants	25	24	24
Mean (Standard Deviation) [Score on a Scale]	0.44 (0.82)	1.08 (1.32)	0.83 (1.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Systane Complete, Sensitive Eyes Rewetting Drops, No Treatment
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	0.30
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline.
Description	The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers.

Arm/Group Title	Systane Complete	Sensitive Eyes Rewetting Drops	No Treatment
Arm/Group Description	Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.	Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.	Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
Measure Participants	25	24	24
Mean (Standard Deviation) [score on a scale]	-8.52 (2.97)	-8.25 (2.42)	-11.50 (3.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Systane Complete, Sensitive Eyes Rewetting Drops, No Treatment
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Two Weeks.
Arm/Group Title	Systane Complete		Sensitive Eyes Rewetting Drops		No Treatment
Arm/Group Description	Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear.		Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Sensitive Eyes Rewetting Drops: Sensitive Eyes Rewetting Drops is a rewetting drop.		Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.
All Cause Mortality
	Systane Complete		Sensitive Eyes Rewetting Drops		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Systane Complete		Sensitive Eyes Rewetting Drops		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Systane Complete		Sensitive Eyes Rewetting Drops		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

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.