Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Eye treatment may lift mood: PROSE lenses tested for depression relief

NCT ID NCT07195721

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 study tests whether PROSE treatment—a custom contact lens that soothes the eye surface—can also improve mental health in people with major depression. Researchers will track depression scores and eye symptoms in 200 adults over time. The goal is to see if treating severe dry eye can lift mood.

What this could mean

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

Active substance
PROSE treatment (a special contact lens that protects the eye surface)
What this could lead to
If it works, this could show that treating severe dry eye with PROSE lenses also eases depression symptoms.
What could go wrong
This is an early-stage trial with no control group, so results may not prove cause and effect. The effect on mood might be small or not last.

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.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

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.

Who is studied

Patients who are being evaluated for PROSE or scleral lens treatment.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Written Informed Consent has been obtained prior to any study-related procedures taking place. 2. Subject is Male or Female, 18 years of age or older prior to the initial visit. 3. Patient is proceeding with a PROSE or scleral lens consultation in one or both eyes for the primary diagnosis of ocular surface disease, including but not limited to Ocular Graft vs Host Disease, Keratoconjunctivitis Sicca, Dry eye, Sjogren's Disease, Rheumatologic ocular surface disease, Exposure Keratitis, Limbal Stem Cell Deficiency, Steven Johnson Syndrome, Mucous Membrane Pemphigoid (Ocular Cicatricial Pemphigoid), Atopic Keratoconjunctivitis, Chemical injury. 4. Baseline PHQ-9 score \> 4 5. Baseline OSDI score of 13 or greater 6. In the opinion of the investigator, the subject can follow study instructions, complete all study procedures and visits 7. Is able to understand the English language in verbal and written interactions - Exclusion Criteria: 1. Is currently participating in any other type of eye-related clinical research study that in the opinion of the investigator would interfere with the study 2. Is pregnant or nursing as reported by the subject. 3. 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. 4. Recently started medication or other therapeutic treatments for affective mood disorders (such as depression) within the last 8 weeks. 5. Recently started new treatment for ocular surface disease, including but not limited to topical medicated drops, procedures, punctal plugs within the last 8 weeks. 6. Ocular surgery within the last 8 weeks 7. Planned ocular surgery within the study period 8. Has a known allergy to topical ophthalmic sodium fluorescein dye 9. Has a known intolerance to topical ophthalmic normal saline 10. Neurotrophic Keratitis 11. Corneal ectasia 12. PROSE or scleral lens wearer within the last 1 year prior to Visit 1 \[subjects who have solely tried a PROSE or scleral lens in an office setting consultation (and were never dispensed for home use) ARE eligible for enrollment, regardless of whether it occurred in the last year\] 13. Is an employee of BostonSight or an employee of a site performing the study -

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Depression - major depressive disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BostonSight

    RECRUITING

    Needham, Massachusetts, 02494, United States

More trials for these conditions

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