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| Name | Class |
|---|---|
| University of Houston | OTHER |
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This study will evaluate Tangible Boost, a new contact lens care product which is designed to replenish the hydrogel layer on fluorosilicone acrylate lenses with Hydra-PEG. The Hydra-PEG coating is a poly(ethylene glycol)-based hydrogel that is covalently bound to the lens surface. This coating improves lens wettability, a common cause of patient discomfort. Tangible Boost is designed to maintain the wettability of Hydra-PEG lenses throughout the lens lifetime. Patients can use the Tangible Boost kit to reapply the Hydra-PEG coating each month at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tangible Boost | Experimental | Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days. |
|
| Control | Placebo Comparator | Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tangible Boost | Device | Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Event Reports or Discontinuations | A report of any adverse events or discontinuations that may have occurred. This measure includes adverse events unrelated to the treatment. See adverse events section for additional details. | Duration of study, 90 +/- 7 days after lens dispense visit. |
| Corneal Staining | Corneal staining with lissamine green was used to identify damage to the corneal cells, which may have been caused by the contact lenses or treatments in the study. 5 regions in each eye were scored on a scale of 0-4, resulting in a total possible range of 0-20. Left and right eye scores were averaged for each subject. A lower score indicates less corneal damage. | 1 day after treatment (day 31), final assessment (day 90) |
| Visual Acuity | Visual acuity was calculated on a logMAR scale using high luminance, high contrast acuity charts. On the logMAR scale, a score of 0 indicates no vision loss, with higher scores indicating more vision loss. | 1 day after treatment (day 31), final assessment (day 90) |
| Non-invasive Tear Film Break-up Time | Tear break-up time was measured with the OCULUS Keratograph. | 1 day after treatment (day 31), final assessment (day 90) |
| Number of Participants With Acceptable Lens Fit | Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone). | final assessment (day 90) |
| Measure | Description | Time Frame |
|---|---|---|
| CLDEQ Score | The Contact Lens Dry Eye Questionnaire (CLDEQ) is used to evaluate the dry eye symptomology of contact lens wearers on a scale of 0-39. A lower score is indicative of greater comfort. | 1 day after treatment (day 31), final assessment (day 90) |
| Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria K Walker, OD MS | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston | Houston | Texas | 77204 | United States |
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| Label | URL |
|---|---|
| Tangible Science website | View source |
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Upon enrollment in the study, patients received Hydra-PEG coated fluorosilicone acrylate RGP contact lenses. Assignment to the Tangible Boost or Control group occurred after 1 month of contact lens wear, on day 30. 4 participants that did not report back for visit 3 on day 30 were excluded from the study prior to assignment to a group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tangible Boost | Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days. Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses. |
| FG001 | Control | Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. Placebo saline: Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution. |
| FG002 | Unassigned | Subjects that did not report back for visit 3 and were therefore not assigned to a treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline measures are provided for all participants who were assigned to a study arm. Participants who dropped out of the study prior to assignment are not included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tangible Boost | Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days. Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients With Adverse Event Reports or Discontinuations | A report of any adverse events or discontinuations that may have occurred. This measure includes adverse events unrelated to the treatment. See adverse events section for additional details. | All subjects enrolled in the study were included in this analysis. | Posted | Count of Participants | Participants | Duration of study, 90 +/- 7 days after lens dispense visit. |
|
3 months
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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 | Tangible Boost | Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days. Tangible Boost: Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Hydrops | Eye disorders | Systematic Assessment |
Decline in performance of the Hydra-PEG lenses was not observed in the control group; therefore, there was little opportunity to see improvements in outcome measures in the treatment group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research and Development | Tangible Science | 650-241-1045 | 108 | kelly@tangiblescience.com |
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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 | Sep 6, 2017 | Sep 29, 2020 | Prot_SAP_ICF_000.pdf |
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2/3 of patients will be assigned to the Tangible Boost treatment arm of the study, and 1/3 of patients will be assigned to the placebo control arm.
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| Placebo saline | Other | Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution. |
|
The subjective comfort of lenses was evaluated on a scale of 0-100, with higher scores indicating better comfort. |
| 1 day after treatment (day 31), final assessment (day 90) |
| Control |
Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. Placebo saline: Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 | Count of Participants | Participants |
|
| Corneal Staining | Corneal staining with lissamine green was used to identify damage to the corneal cells, which could have been caused by the contact lenses or treatments in the study. 5 regions in each eye were score on a scale of 0-4, resulting in a total possible range of 0-20. A higher score indicates more corneal damage. Left and right eye scores were averaged for each subject. Baseline data was collected after 1 month of lens wear in the study just prior to initial lens treatment with Tangible Boost or placebo control. | Median | Inter-Quartile Range | units on a scale |
|
| Visual Acuity (logMAR) | Visual acuity was calculated on a logMAR scale using high luminance, high contrast acuity charts. Baseline measurements were collected after 1 month of lens wear, prior to treatment with Tangible Boost or the placebo solution. A score of "0" indicates no vision loss, with higher scores indicating poorer vision. | Median | Inter-Quartile Range | units on a scale |
|
| Non-invasive tear film break-up time | Tear break-up time was measured with the OCULUS Keratograph prior to lens treatment with Tangible Boost or the placebo, after 1 month of lens wear in the study. | Mean | Standard Deviation | seconds |
|
| Lens Fit | Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone). | Count of Participants | Participants |
|
| CLDEQ Score | The Contact Lens Dry Eye Questionnaire (CLDEQ) is used to evaluate the dry eye symptomology of contact lens wearers on a scale of 0-39. A lower score is indicative of greater comfort. Baseline measurements were collected prior to lens treatment after 1 month of lens wear. | Mean | Standard Deviation | units on a scale |
|
| Visual Analog Scale (VAS) | The subjective comfort of lenses was evaluated on a scale of 1-100, with higher scores indicating better comfort. | Mean | Standard Deviation | units on a scale |
|
| Control |
Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. Placebo saline: Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution. |
| OG002 | Unassigned | Dropped out of study prior to assignment. |
|
|
| Primary | Corneal Staining | Corneal staining with lissamine green was used to identify damage to the corneal cells, which may have been caused by the contact lenses or treatments in the study. 5 regions in each eye were scored on a scale of 0-4, resulting in a total possible range of 0-20. Left and right eye scores were averaged for each subject. A lower score indicates less corneal damage. | All participants that were assigned to a study arm. | Posted | Median | Inter-Quartile Range | score on a scale | 1 day after treatment (day 31), final assessment (day 90) |
|
|
|
|
| Primary | Visual Acuity | Visual acuity was calculated on a logMAR scale using high luminance, high contrast acuity charts. On the logMAR scale, a score of 0 indicates no vision loss, with higher scores indicating more vision loss. | All participants assigned to a study arm. | Posted | Median | Inter-Quartile Range | logMAR visual acuity | 1 day after treatment (day 31), final assessment (day 90) |
|
|
|
|
| Primary | Non-invasive Tear Film Break-up Time | Tear break-up time was measured with the OCULUS Keratograph. | All participants that were assigned to a study arm. 1 participant was excluded due to malfunction of the keratograph during their visit. | Posted | Mean | Standard Deviation | seconds | 1 day after treatment (day 31), final assessment (day 90) |
|
|
|
|
| Primary | Number of Participants With Acceptable Lens Fit | Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone). | All participants that were assigned to a study arm. | Posted | Count of Participants | Participants | final assessment (day 90) |
|
|
|
| Secondary | CLDEQ Score | The Contact Lens Dry Eye Questionnaire (CLDEQ) is used to evaluate the dry eye symptomology of contact lens wearers on a scale of 0-39. A lower score is indicative of greater comfort. | All participants that were assigned to a study group. | Posted | Mean | Standard Deviation | score on a scale | 1 day after treatment (day 31), final assessment (day 90) |
|
|
|
|
| Secondary | Visual Analog Scale (VAS) | The subjective comfort of lenses was evaluated on a scale of 0-100, with higher scores indicating better comfort. | All participants that were assigned to a study arm. | Posted | Mean | Standard Deviation | score on a scale | 1 day after treatment (day 31), final assessment (day 90) |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 4 |
| 21 |
| EG001 | Control | Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. Placebo saline: Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | Unassigned | Dropped out of study prior to assignment. | 0 | 4 | 0 | 4 | 1 | 4 |
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asymptomatic keratitis | Eye disorders | Systematic Assessment |
|
| Mild, allergic-type reaction | Eye disorders | Systematic Assessment |
|
| Acute inflammatory conjunctivitis | Eye disorders | Systematic Assessment |
|
| Mild conjunctival inflammation | Eye disorders | Systematic Assessment |
|
| Preservative toxicity-type corneal sensitivity | Eye disorders | Systematic Assessment | Occurs in scleral lens wearers when preservatives remain in the lens bowl. |
|
| Contact lens associated red eye | Eye disorders | Systematic Assessment |
|
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Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.
| 0.9917 |
| Equivalence |
alpha = 0.05 |
Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.
| 0.8343 |
| Equivalence |
alpha = 0.05 |
Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.
| 0.1192 |
| Equivalence |
alpha = 0.05 |
| ANOVA |
Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment. |
| 0.1843 |
| Equivalence |
alpha = 0.05 |
Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.
| 0.1520 |
| Equivalence |
alpha = 0.05 |