Contact Lens Solution
Conditions
Keywords
Contact Lens Care Accessory
Brief summary
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.
Interventions
DEVICETangible Boost
Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses.
OTHERPlacebo saline
Participants will treat their lenses with a placebo Tangible Boost kit, which contains saline in place of the Tangible Boost solution.
Sponsors
University of Houston
Tangible Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Habitual contact lens wear with a group 3 FDA approved rigid lens material, with 20-50% of subjects wearing corneal lenses * Willing and able to sign the informed consent form * 18 years or older
Exclusion criteria
* Eye injury or surgery within the 3 months immediately prior to enrollment for this trial * Pre-existing ocular irritation that would preclude contact lens fitting * Current enrollment in an ophthalmic clinical trial * Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator * Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator * Pregnant women and nursing mothers * Visual acuity less than 20/20 when best corrected with contact lenses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | 1 day after treatment (day 31), final assessment (day 90) | 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. |
| Non-invasive Tear Film Break-up Time | 1 day after treatment (day 31), final assessment (day 90) | Tear break-up time was measured with the OCULUS Keratograph. |
| Number of Participants With Acceptable Lens Fit | final assessment (day 90) | Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone). |
| Number of Patients With Adverse Event Reports or Discontinuations | Duration of study, 90 +/- 7 days after lens dispense visit. | 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. |
| Visual Acuity | 1 day after treatment (day 31), final assessment (day 90) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 1 day after treatment (day 31), final assessment (day 90) | The subjective comfort of lenses was evaluated on a scale of 0-100, with higher scores indicating better comfort. |
| CLDEQ Score | 1 day after treatment (day 31), final assessment (day 90) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 10 |
| Total | 31 |
Baseline characteristics
| Characteristic | Tangible Boost | Control | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 16 | 46 years STANDARD_DEVIATION 16 | 47 years STANDARD_DEVIATION 15 |
| CLDEQ Score | 16 units on a scale STANDARD_DEVIATION 7 | 10 units on a scale STANDARD_DEVIATION 8 | 14 units on a scale STANDARD_DEVIATION 8 |
| Corneal Staining | 2.0 units on a scale | 2.0 units on a scale | 2.0 units on a scale |
| Lens Fit | 21 Participants | 10 Participants | 31 Participants |
| Non-invasive tear film break-up time | 17.40 seconds STANDARD_DEVIATION 4.81 | 14.91 seconds STANDARD_DEVIATION 6.48 | 16.59 seconds STANDARD_DEVIATION 5.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 21 Participants | 10 Participants | 31 Participants |
| Sex: Female, Male Female | 15 Participants | 4 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
| Visual Acuity (logMAR) | 0.11 units on a scale | 0.11 units on a scale | 0.11 units on a scale |
| Visual Analog Scale (VAS) | 64 units on a scale STANDARD_DEVIATION 28 | 84 units on a scale STANDARD_DEVIATION 22 | 73 units on a scale STANDARD_DEVIATION 26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 10 | 0 / 4 |
| other Total, other adverse events | 4 / 21 | 2 / 10 | 1 / 4 |
| serious Total, serious adverse events | 0 / 21 | 0 / 10 | 0 / 4 |
Outcome results
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.
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Population: All participants that were assigned to a study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tangible Boost | Corneal Staining | 1 day after treatment | 2.25 score on a scale |
| Tangible Boost | Corneal Staining | Final assessment | 1.5 score on a scale |
| Control | Corneal Staining | Final assessment | 1.75 score on a scale |
| Control | Corneal Staining | 1 day after treatment | 2.00 score on a scale |
p-value: 0.3577ANOVA
p-value: 0.9917ANOVA
Primary
Non-invasive Tear Film Break-up Time
Tear break-up time was measured with the OCULUS Keratograph.
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Population: All participants that were assigned to a study arm. 1 participant was excluded due to malfunction of the keratograph during their visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tangible Boost | Non-invasive Tear Film Break-up Time | 1 day after treatment | 16.27 seconds | Standard Deviation 4.32 |
| Tangible Boost | Non-invasive Tear Film Break-up Time | final assessment | 15.84 seconds | Standard Deviation 4.64 |
| Control | Non-invasive Tear Film Break-up Time | 1 day after treatment | 19.84 seconds | Standard Deviation 6.37 |
| Control | Non-invasive Tear Film Break-up Time | final assessment | 18.30 seconds | Standard Deviation 3.49 |
p-value: 0.4134ANOVA
p-value: 0.1192ANOVA
Primary
Number of Participants With Acceptable Lens Fit
Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).
Time frame: final assessment (day 90)
Population: All participants that were assigned to a study arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tangible Boost | Number of Participants With Acceptable Lens Fit | 21 Participants |
| Control | Number of Participants With Acceptable Lens Fit | 10 Participants |
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.
Time frame: Duration of study, 90 +/- 7 days after lens dispense visit.
Population: All subjects enrolled in the study were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tangible Boost | Number of Patients With Adverse Event Reports or Discontinuations | 4 Participants |
| Control | Number of Patients With Adverse Event Reports or Discontinuations | 2 Participants |
| Unassigned | Number of Patients With Adverse Event Reports or Discontinuations | 4 Participants |
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.
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Population: All participants assigned to a study arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tangible Boost | Visual Acuity | 1 day after treatment | 0.12 logMAR visual acuity |
| Tangible Boost | Visual Acuity | final assessment | 0.140 logMAR visual acuity |
| Control | Visual Acuity | 1 day after treatment | 0.095 logMAR visual acuity |
| Control | Visual Acuity | final assessment | 0.060 logMAR visual acuity |
p-value: 0.3239ANOVA
p-value: 0.8343ANOVA
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.
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Population: All participants that were assigned to a study group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tangible Boost | CLDEQ Score | 1 day after treatment | 14.2 score on a scale | Standard Deviation 8.9 |
| Tangible Boost | CLDEQ Score | final assessment | 16.7 score on a scale | Standard Deviation 8 |
| Control | CLDEQ Score | 1 day after treatment | 7.9 score on a scale | Standard Deviation 7.7 |
| Control | CLDEQ Score | final assessment | 11.4 score on a scale | Standard Deviation 9.5 |
p-value: 0.1753ANOVA
p-value: 0.1843ANOVA
Secondary
Visual Analog Scale (VAS)
The subjective comfort of lenses was evaluated on a scale of 0-100, with higher scores indicating better comfort.
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Population: All participants that were assigned to a study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tangible Boost | Visual Analog Scale (VAS) | 1 day after treatment | 78 score on a scale | Standard Deviation 23 |
| Tangible Boost | Visual Analog Scale (VAS) | final assessment | 75 score on a scale | Standard Deviation 22 |
| Control | Visual Analog Scale (VAS) | 1 day after treatment | 93 score on a scale | Standard Deviation 9 |
| Control | Visual Analog Scale (VAS) | final assessment | 84 score on a scale | Standard Deviation 20 |
p-value: 0.0765ANOVA
p-value: 0.152ANOVA