Evaluation of Tangible Boost Replenishing System
Completed · Not applicable · Has a placebo group
Conditions studied: Contact Lens Solution
In brief
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.
Key facts
- Study ID
- NCT03073148
- Run by
- Tangible Science
- People needed
- 35
- Starts
- 2017-02-24
- Expected to finish
- 2019-02-13
- Last updated by the study team
- 2020-11-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 18 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
Where it is running
- University of Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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