MedDataX Logo

Evaluation of Tangible Boost Replenishing System

NCT ID: NCT03073148

Last Updated: 2020-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-24

Study Completion Date

2019-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contact Lens Solution

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Contact Lens Care Accessory

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tangible Boost

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

Group Type EXPERIMENTAL

Tangible Boost

Intervention Type DEVICE

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebo saline

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tangible Boost

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

Intervention Type DEVICE

Placebo saline

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Houston

OTHER

Sponsor Role collaborator

Tangible Science

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria K Walker, OD MS

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.tangiblescience.com

Tangible Science website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113133

Identifier Type: -

Identifier Source: org_study_id