N/A
N=35
Evaluation of Tangible Boost Replenishing System
Contact Lens Solution
Bottom Line
View on ClinicalTrials.gov: NCT03073148 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Patients With Adverse Event Reports or Discontinuations — 4; 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tangible Boost (Device); Placebo saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tangible Science
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Event Reports or Discontinuations |
4; 2; 4 | — |
| PRIMARY Corneal Staining |
2.25; 2.00; 1.5; 1.75 | 0.3577 |
| PRIMARY Visual Acuity |
0.12; 0.095; 0.140; 0.060 | 0.3239 |
| PRIMARY Non-invasive Tear Film Break-up Time |
16.27; 19.84; 15.84; 18.30 | 0.4134 |
| PRIMARY Number of Participants With Acceptable Lens Fit |
21; 10 | — |
| SECONDARY CLDEQ Score |
14.2; 7.9; 16.7; 11.4 | 0.1753 |
| SECONDARY Visual Analog Scale (VAS) |
78; 93; 75; 84 | 0.0765 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03073148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.