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Eye insert could ease allergy symptoms for contact lens wearers

NCT ID NCT04418999

Symptom relief Sponsor: Illinois College of Optometry 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested a dexamethasone eye insert placed by a doctor against a standard steroid gel for treating allergy and dry eye symptoms in 36 people with keratoconus who wear gas permeable contact lenses. The goal was to see if the insert improves signs like eyelid bumps and eye dryness better than the gel. Results may point to a simpler treatment option that doesn't require daily drops.

What this could mean

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

Active substance
dexamethasone ophthalmic insert
What this could lead to
If it works, this could offer a more convenient, doctor-administered treatment for allergy and dry eye symptoms in keratoconus patients who wear contact lenses.
What could go wrong
This is a very early, small trial with only 36 participants, so results may not be conclusive. The insert may not work better than the standard gel, and there are risks like increased eye pressure.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

36 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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: * 18 years of age or older * Bilateral Keratoconus * Bilateral RGP contact lenses * Bilateral allergic conjunctivitis as determined by the Papillae Efron Scale score of at least 1 and symptoms of itching * Bilateral underlying dry eye disease as determined by the NEI Fluorescein Staining Scale score of at least 1 and a TBUT of less than 10 and must correlate with dryness on OSDI Exclusion Criteria: * Patients under the age of 18. * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone * Patients being treated with immunomodulating agents in the study eye(s) * Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

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Conditions

The condition(s) this trial relates to.

allergic disease atopic conjunctivitis dry eye syndrome keratoconus

As listed by the trial registrant

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

Allergy Dry eye Keratoconus

Contacts and locations

Locations

  • Illinois Eye Institute

    Chicago, Illinois, 60616, United States

More trials for these conditions

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