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Contact lens coating replenisher tested for rare eye conditions

NCT ID NCT04313725

Symptom relief Sponsor: Tangible Science Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a monthly solution called Tangible Boost that is meant to restore a special coating on contact lenses. The goal was to see if it could improve comfort and vision in people with severe dry eye from Stevens-Johnson syndrome, Sjogren's syndrome, or graft-versus-host disease. The trial was terminated early and included only 28 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tangible Boost (a monthly conditioning solution for contact lenses)
What this could lead to
If it works, this could provide a simple monthly treatment to improve comfort and vision for people with severe dry eye from these conditions.
What could go wrong
The trial was terminated early with only 28 participants, so results are limited. It is a small, early-stage study, and the device may not provide lasting benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Feb 2020

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written Informed Consent has been obtained prior to any study-related procedures taking place * Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable * Male or female * 18 years of age and older prior to the initial visit * Is a new or established wearer of PROSE lenses with optimized lens fit prior to enrollment in the study * Has been diagnosed with Dry Eye Syndrome, SJS, SS, or GVHD * In the opinion of the investigator, the subject has the ability to follow study instructions * In the opinion of the investigator, the subject has the ability to complete all study procedures and visits Exclusion Criteria: * aphakic (i.e., missing their natural lens inside the eye) * Is currently participating in any other type of eye-related clinical or research study * Is pregnant or nursing as reported by the subject * Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study. * Has a known and self-reported allergy to the following substances: polyethylene glycol, polyvinyl alcohol, triethanolamine, polyquaternium-1, or edetate disodium, which are components of the Tangible Boost and Hydra-PEG systems or care regimen. * Has had previous ocular surgery within the past 12 weeks * Adults unable to consent (including adults unable to read and understand English) * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners * Employees of BostonSight

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Conditions

The condition(s) this trial relates to.

dry eye syndrome graft versus host disease Sjogren syndrome Stevens-Johnson syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye Graft versus host disease in eye Sjogren's syndrome Stevens-Johnson syndrome

Contacts and locations

Locations

  • Boston Sight

    Needham, Massachusetts, 02494, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.