Clinical trial NCT03073148: Evaluation of Tangible Boost Replenishing System
Official title: Evaluation of Tangible Boost Replenishing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solution
Keywords: Contact Lens Care Accessory
Lead sponsor: Tangible Science
Sponsor class: INDUSTRY
Collaborators: name: University of Houston
First posted: 2017-03-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of Patients With Adverse Event Reports or Discontinuations
timeFrame: Duration of study, 90 +/- 7 days after lens dispense visit.
measure: Corneal Staining
timeFrame: 1 day after treatment (day 31), final assessment (day 90)
measure: Visual Acuity
timeFrame: 1 day after treatment (day 31), final assessment (day 90)
measure: Non-invasive Tear Film Break-up Time
timeFrame: 1 day after treatment (day 31), final assessment (day 90)
measure: Number of Participants With Acceptable Lens Fit
timeFrame: final assessment (day 90)
Secondary outcomes:
measure: CLDEQ Score
timeFrame: 1 day after treatment (day 31), final assessment (day 90)
measure: Visual Analog Scale (VAS)
timeFrame: 1 day after treatment (day 31), final assessment (day 90)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Maria K Walker, OD MS
role: PRINCIPAL_INVESTIGATOR
References: