Trial Outcomes & Findings for Evaluation of Tangible Boost Replenishing System (NCT NCT03073148)
NCT ID: NCT03073148
Last Updated: 2020-11-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Duration of study, 90 +/- 7 days after lens dispense visit.
Results posted on
2020-11-17
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
Unassigned
Subjects that did not report back for visit 3 and were therefore not assigned to a treatment group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
10
|
4
|
|
Overall Study
COMPLETED
|
21
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 16 • n=21 Participants
|
46 years
STANDARD_DEVIATION 16 • n=10 Participants
|
47 years
STANDARD_DEVIATION 15 • n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
21 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
31 Participants
n=31 Participants
|
|
Corneal Staining
|
2.0 units on a scale
n=21 Participants
|
2.0 units on a scale
n=10 Participants
|
2.0 units on a scale
n=31 Participants
|
|
Visual Acuity (logMAR)
|
0.11 units on a scale
n=21 Participants
|
0.11 units on a scale
n=10 Participants
|
0.11 units on a scale
n=31 Participants
|
|
Non-invasive tear film break-up time
|
17.40 seconds
STANDARD_DEVIATION 4.81 • n=21 Participants
|
14.91 seconds
STANDARD_DEVIATION 6.48 • n=10 Participants
|
16.59 seconds
STANDARD_DEVIATION 5.60 • n=31 Participants
|
|
Lens Fit
|
21 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
31 Participants
n=31 Participants
|
|
CLDEQ Score
|
16 units on a scale
STANDARD_DEVIATION 7 • n=21 Participants
|
10 units on a scale
STANDARD_DEVIATION 8 • n=10 Participants
|
14 units on a scale
STANDARD_DEVIATION 8 • n=31 Participants
|
|
Visual Analog Scale (VAS)
|
64 units on a scale
STANDARD_DEVIATION 28 • n=21 Participants
|
84 units on a scale
STANDARD_DEVIATION 22 • n=10 Participants
|
73 units on a scale
STANDARD_DEVIATION 26 • n=31 Participants
|
PRIMARY outcome
Timeframe: Duration of study, 90 +/- 7 days after lens dispense visit.Population: All subjects enrolled in the study were included in this analysis.
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.
Outcome measures
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
n=4 Participants
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Number of Patients With Adverse Event Reports or Discontinuations
|
4 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 1 day after treatment (day 31), final assessment (day 90)Population: All participants that were assigned to a study arm.
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.
Outcome measures
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Corneal Staining
1 day after treatment
|
2.25 score on a scale
Interval 0.5 to 5.125
|
2.00 score on a scale
Interval 0.75 to 4.5
|
—
|
|
Corneal Staining
Final assessment
|
1.5 score on a scale
Interval 0.0 to 3.25
|
1.75 score on a scale
Interval 0.75 to 4.375
|
—
|
PRIMARY outcome
Timeframe: 1 day after treatment (day 31), final assessment (day 90)Population: All participants assigned to a study arm.
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.
Outcome measures
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Visual Acuity
1 day after treatment
|
0.12 logMAR visual acuity
Interval -0.025 to 0.165
|
0.095 logMAR visual acuity
Interval -0.07 to 0.225
|
—
|
|
Visual Acuity
final assessment
|
0.140 logMAR visual acuity
Interval 0.02 to 0.225
|
0.060 logMAR visual acuity
Interval -0.0225 to 0.2725
|
—
|
PRIMARY outcome
Timeframe: 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.
Tear break-up time was measured with the OCULUS Keratograph.
Outcome measures
| Measure |
Tangible Boost
n=20 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Non-invasive Tear Film Break-up Time
1 day after treatment
|
16.27 seconds
Standard Deviation 4.32
|
19.84 seconds
Standard Deviation 6.37
|
—
|
|
Non-invasive Tear Film Break-up Time
final assessment
|
15.84 seconds
Standard Deviation 4.64
|
18.30 seconds
Standard Deviation 3.49
|
—
|
PRIMARY outcome
Timeframe: final assessment (day 90)Population: All participants that were assigned to a study arm.
Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).
Outcome measures
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Number of Participants With Acceptable Lens Fit
|
21 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 day after treatment (day 31), final assessment (day 90)Population: All participants that were assigned to a study group.
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.
Outcome measures
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
CLDEQ Score
1 day after treatment
|
14.2 score on a scale
Standard Deviation 8.9
|
7.9 score on a scale
Standard Deviation 7.7
|
—
|
|
CLDEQ Score
final assessment
|
16.7 score on a scale
Standard Deviation 8.0
|
11.4 score on a scale
Standard Deviation 9.5
|
—
|
SECONDARY outcome
Timeframe: 1 day after treatment (day 31), final assessment (day 90)Population: All participants that were assigned to a study arm.
The subjective comfort of lenses was evaluated on a scale of 0-100, with higher scores indicating better comfort.
Outcome measures
| Measure |
Tangible Boost
n=21 Participants
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.
|
Control
n=10 Participants
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.
|
Unassigned
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Visual Analog Scale (VAS)
final assessment
|
75 score on a scale
Standard Deviation 22
|
84 score on a scale
Standard Deviation 20
|
—
|
|
Visual Analog Scale (VAS)
1 day after treatment
|
78 score on a scale
Standard Deviation 23
|
93 score on a scale
Standard Deviation 9
|
—
|
Adverse Events
Tangible Boost
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Unassigned
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tangible Boost
n=21 participants at risk
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.
|
Control
n=10 participants at risk
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.
|
Unassigned
n=4 participants at risk
Dropped out of study prior to assignment.
|
|---|---|---|---|
|
Eye disorders
Corneal Hydrops
|
0.00%
0/21 • 3 months
|
0.00%
0/10 • 3 months
|
25.0%
1/4 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/4 • 3 months
|
|
Eye disorders
Asymptomatic keratitis
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/4 • 3 months
|
|
Eye disorders
Mild, allergic-type reaction
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/4 • 3 months
|
|
Eye disorders
Acute inflammatory conjunctivitis
|
0.00%
0/21 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
0.00%
0/4 • 3 months
|
|
Eye disorders
Mild conjunctival inflammation
|
0.00%
0/21 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
0.00%
0/4 • 3 months
|
|
Eye disorders
Preservative toxicity-type corneal sensitivity
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/4 • 3 months
|
|
Eye disorders
Contact lens associated red eye
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/4 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place