Skip to main content
OpenTrials
Completed

NCT Number: NCT03073148

Evaluation of Tangible Boost Replenishing System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contact Lens Solution

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston

Houston, Texas, 77204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo saline

Other

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

Primary outcomes

  1. Number of Patients With Adverse Event Reports or Discontinuations

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: final assessment (day 90)

    Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).

Secondary outcomes

  1. CLDEQ Score

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tangible Science

Industry

Collaborators

  • University of Houston

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2017
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.