Evaluation of Tangible Boost Replenishing System

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Tangible Boost Replenishing System

Conditions
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Contact Lens Solution

Intervention / Treatment
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* Device: Tangible Boost
* Other: Placebo saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens Care Accessory