- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682809
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
March 23, 2020 updated by: Andrew Pucker, University of Alabama at Birmingham
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
New York
-
Babylon, New York, United States, 11702
- Lindenhurst Eye Physicians & Surgeons, P.C.
-
-
Tennessee
-
Memphis, Tennessee, United States, 38104
- Southern College of Optometry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contact Lens Symptoms
Time Frame: 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.
|
Baseline through 2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
End of Day Eye Comfort
Time Frame: 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.
|
Baseline through 2 Weeks
|
Corneal Staining
Time Frame: 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.
|
Baseline through 2 Weeks
|
Schirmer's I Test Without Anesthetic
Time Frame: 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.
|
Baseline through 2 Weeks
|
Tear Break-Up Time (TBUT)
Time Frame: 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.
|
Baseline through 2 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2018
Primary Completion (Actual)
March 23, 2019
Study Completion (Actual)
March 23, 2019
Study Registration Dates
First Submitted
September 21, 2018
First Submitted That Met QC Criteria
September 21, 2018
First Posted (Actual)
September 25, 2018
Study Record Updates
Last Update Posted (Actual)
April 6, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000522017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There are no plans to share individual subject's data.
Data will only be published in aggregate form.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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