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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Complete | Experimental | Subjects in this group will use Systane Complete before, during, and after contact lens use. |
|
| Sensitive Eyes Rewetting Drops | Active Comparator | Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. |
|
| No Treatment | No Intervention | Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Complete | Drug | Systane Complete is an artificial tear. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two 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. | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic. | 2 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Lindenhurst Eye Physicians & Surgeons, P.C. |
There is no plan to share individual subject data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Complete | Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear. |
| FG001 | Sensitive Eyes Rewetting Drops | 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. |
| FG002 | No Treatment | Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects were included if they were generally healthy adult (18 years or older) contact lens wearer who had significant contact lens and dry eye questionnaire cldeq8 scores of 12 or greater.
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane Complete | Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear. |
| BG001 | Sensitive Eyes Rewetting Drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two 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. | Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers. | Posted | Mean | Standard Deviation | Score on a Scale | 2 Weeks |
|
Two Weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Systane Complete | Subjects in this group will use Systane Complete before, during, and after contact lens use. Systane Complete: Systane Complete is an artificial tear. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Pucker | The University of Alabama at Birmingham | 920-579-2900 | apucker@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 22, 2019 | Sep 21, 2020 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Investigator Masked, Randomized, Clinical Trial
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The investigator will be masked to the subject's treatment. The subjects cannot be fully masked because there is a no treatment control group.
| Sensitive Eyes Rewetting Drops |
| Drug |
Sensitive Eyes Rewetting Drops is a rewetting drop. |
|
| Babylon |
| New York |
| 11702 |
| United States |
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
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.
| BG002 | No Treatment | Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sensitive Eyes Rewetting Drops | 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. |
| OG002 | No Treatment | Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. |
|
|
|
| Secondary | 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. | The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic. | Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers. | Posted | Mean | Standard Deviation | score on a scale | 2 Weeks |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Sensitive Eyes Rewetting Drops | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | No Treatment | Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|