Evaluation of Tangible Boost Replenishing System

Tangible Science35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Contact Lens Solution

Interventions

Tangible BoostDEVICE

Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses.

Placebo salineOTHER

Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

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)

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)

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)

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)

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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