Direct Application of Systane Complete to Contact Lenses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03848221|
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : December 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Contact Lens Complication||Drug: Systane Complete Drug: Sensitive Eyes Rewetting Drops||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Investigator 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.|
|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 :||October 20, 2019|
|Actual Study Completion Date :||October 20, 2019|
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.
- Percentage of participants with ocular surface damage as measured by the Brien Holden Vision Institute (BHVI grading scale) [ Time Frame: Baseline through 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.
- Identifying contact lens (CL) participants with dry eye disease (DED), as measured by the Contact Lens Dry Eye Questionnaire-4 items (CLDEQ-4). [ Time Frame: Baseline through 2 Weeks ]The CLDEQ-4 is a contact lens specific symptoms survey, we are using the Rasch validated version; range = 0-18 with 18 being most symptomatic.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848221
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, New York|
|Lindenhurst Eye Physicians & Surgeons, P.C.|
|Babylon, New York, United States, 11702|
|United States, Tennessee|
|Southern College of Optometry|
|Memphis, Tennessee, United States, 38104|