Evaluation of Tangible Boost Replenishing System

NCT03073148 | Completed Results FDA Device

• 1 other identifier: 113133
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Solution

Keywords

Contact Lens Care Accessory

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• CLDEQ Score

  1 day after treatment (day 31), final assessment (day 90)

• Visual Analog Scale (VAS)

  1 day after treatment (day 31), final assessment (day 90)

Study Arms (2)

Tangible Boost

EXPERIMENTAL

Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days.

Device: Tangible Boost

Control

PLACEBO COMPARATOR

Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days.

Other: Placebo saline

Interventions

Tangible Boost DEVICE

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

Tangible Boost

Placebo saline OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Tangible Science: lead
• University of Houston: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Links

• Tangible Science website

Limitations and 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.

Results Point of Contact

• Title: Director of Research and Development
• Organization: Tangible Science

kelly@tangiblescience.com

650-241-1045

Study Officials

• Maria K Walker, OD MS

  University of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 8, 2017
• Study Start: February 24, 2017
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-10

Locations

US (1)