Evaluation of Tangible Boost Replenishing System

• Sponsor: Tangible Science (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03073148
• Collaborator: University of Houston (Other)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Solution	Device: Tangible Boost; Other: Placebo saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Tangible Boost Replenishing System
• Actual Study Start Date: Feb 24, 2017
• Actual Primary Completion Date: Feb 13, 2019
• Actual Study Completion Date: Feb 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tangible Boost Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days.	Device: Tangible Boost; Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses.
Placebo Comparator: Control Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days.	Other: Placebo saline; Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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).

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston	Houston	Texas	United States	77204

Sponsors and Collaborators

• Tangible Science
• University of Houston

Investigators

• Principal Investigator: Maria K Walker, OD MS, University of Houston

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 6, 2017

More Information

Additional Information:

• Tangible Science website

Publications

None provided.

• Responsible Party: Tangible Science
• ClinicalTrials.gov Identifier: NCT03073148
• Other Study ID Numbers: 113133
• First Posted: Mar 8, 2017
• Last Update Posted: Nov 17, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Tangible Science: Contact Lens Care Accessory

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Tangible Boost	Control	Unassigned
Arm/Group Description	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.	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.	Subjects that did not report back for visit 3 and were therefore not assigned to a treatment group.
Period Title: Overall Study
STARTED	21	10	4
COMPLETED	21	10	0
NOT COMPLETED	0	0	4

Baseline Characteristics

Arm/Group Title	Tangible Boost	Control	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	21	10	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (16)	46 (16)	47 (15)
Sex: Female, Male (Count of Participants)
Female	15 71.4%	4 40%	19 61.3%
Male	6 28.6%	6 60%	12 38.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	21 100%	10 100%	31 100%
Corneal Staining (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	2.0	2.0	2.0
Visual Acuity (logMAR) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	0.11	0.11	0.11
Non-invasive tear film break-up time (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	17.40 (4.81)	14.91 (6.48)	16.59 (5.60)
Lens Fit (Count of Participants)
Count of Participants [Participants]	21 100%	10 100%	31 100%
CLDEQ Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	16 (7)	10 (8)	14 (8)
Visual Analog Scale (VAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	64 (28)	84 (22)	73 (26)

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Adverse Event Reports or Discontinuations
Description	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.

Outcome Measure Data

Analysis Population Description

All subjects enrolled in the study were included in this analysis.

Arm/Group Title	Tangible Boost	Control	Unassigned
Arm/Group Description	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.	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.	Dropped out of study prior to assignment.
Measure Participants	21	10	4
Count of Participants [Participants]	4 19%	2 20%	4 12.9%

2. Primary Outcome

Title	Corneal Staining
Description	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)

Outcome Measure Data

Analysis Population Description

All participants that were assigned to a study arm.

Arm/Group Title	Tangible Boost	Control
Arm/Group Description	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.	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.
Measure Participants	21	10
1 day after treatment	2.25	2.00
Final assessment	1.5	1.75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tangible Boost
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.3577
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.9917
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

3. Primary Outcome

Title	Visual Acuity
Description	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)

Outcome Measure Data

Analysis Population Description

All participants assigned to a study arm.

Arm/Group Title	Tangible Boost	Control
Arm/Group Description	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.	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.
Measure Participants	21	10
1 day after treatment	0.12	0.095
final assessment	0.140	0.060

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tangible Boost
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.3239
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.8343
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

4. Primary Outcome

Title	Non-invasive Tear Film Break-up Time
Description	Tear break-up time was measured with the OCULUS Keratograph.
Time Frame	1 day after treatment (day 31), final assessment (day 90)

Outcome Measure Data

Analysis Population Description

All participants that were assigned to a study arm. 1 participant was excluded due to malfunction of the keratograph during their visit.

Arm/Group Title	Tangible Boost	Control
Arm/Group Description	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.	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.
Measure Participants	20	10
1 day after treatment	16.27 (4.32)	19.84 (6.37)
final assessment	15.84 (4.64)	18.30 (3.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tangible Boost
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.4134
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.1192
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

5. Primary Outcome

Title	Number of Participants With Acceptable Lens Fit
Description	Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).
Time Frame	final assessment (day 90)

Outcome Measure Data

Analysis Population Description

All participants that were assigned to a study arm.

Arm/Group Title	Tangible Boost	Control
Arm/Group Description	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.	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.
Measure Participants	21	10
Count of Participants [Participants]	21 100%	10 100%

6. Secondary Outcome

Title	CLDEQ Score
Description	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)

Outcome Measure Data

Analysis Population Description

All participants that were assigned to a study group.

Arm/Group Title	Tangible Boost	Control
Arm/Group Description	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.	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.
Measure Participants	21	10
1 day after treatment	14.2 (8.9)	7.9 (7.7)
final assessment	16.7 (8.0)	11.4 (9.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tangible Boost
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.1753
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.1843
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

7. Secondary Outcome

Title	Visual Analog Scale (VAS)
Description	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)

Outcome Measure Data

Analysis Population Description

All participants that were assigned to a study arm.

Arm/Group Title	Tangible Boost	Control
Arm/Group Description	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.	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.
Measure Participants	21	10
1 day after treatment	78 (23)	93 (9)
final assessment	75 (22)	84 (20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tangible Boost
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.0765
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments
	Type of Statistical Test	Equivalence
	Comments	alpha = 0.05
Statistical Test of Hypothesis	p-Value	0.1520
	Comments
	Method	ANOVA
	Comments	Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.

Adverse Events

Time Frame	3 months
Arm/Group Title	Tangible Boost		Control		Unassigned
Arm/Group Description	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.		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.		Dropped out of study prior to assignment.
All Cause Mortality
	Tangible Boost		Control		Unassigned
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/10 (0%)		0/4 (0%)
Serious Adverse Events
	Tangible Boost		Control		Unassigned
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/10 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Tangible Boost		Control		Unassigned
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/21 (19%)		2/10 (20%)		1/4 (25%)
Eye disorders
Corneal Hydrops	0/21 (0%)	0	0/10 (0%)	0	1/4 (25%)	1
Asymptomatic keratitis	1/21 (4.8%)	1	0/10 (0%)	0	0/4 (0%)	0
Mild, allergic-type reaction	1/21 (4.8%)	1	0/10 (0%)	0	0/4 (0%)	0
Acute inflammatory conjunctivitis	0/21 (0%)	0	1/10 (10%)	1	0/4 (0%)	0
Mild conjunctival inflammation	0/21 (0%)	0	1/10 (10%)	1	0/4 (0%)	0
Preservative toxicity-type corneal sensitivity	1/21 (4.8%)	1	0/10 (0%)	0	0/4 (0%)	0
Contact lens associated red eye	1/21 (4.8%)	1	0/10 (0%)	0	0/4 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory Infection	1/21 (4.8%)	1	0/10 (0%)	0	0/4 (0%)	0

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.