CompletedPhase 2

Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

United States20 participantsStarted 2012-06

Plain-language summary

This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria * Ocular symptoms of NIH eye score 2 or greater: * Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops \> 3 x per day or punctal plugs), WITHOUT vision impairment * Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis * No new systemic immunosuppressive medications within 1 month prior to enrollment * Subject has the ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Absolute neutrophil count \< 1000/ul * Known hypersensitivity or allergy to contact lenses * Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment * Treatment with contact lenses within the previous 3 months for any indication * Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale

Timeframe: 3 months

Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale

Timeframe: 3 months

Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index

Timeframe: 3 months

Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI

Timeframe: 3 months

Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale

Timeframe: 3 months

Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale

Timeframe: 3 months

Trial details

NCT IDNCT01616056

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

Results submitted2017-01-13

View on ClinicalTrials.gov More Graft Versus Host Disease trials

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale

Timeframe: 3 months

Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale

Timeframe: 3 months

Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index

Timeframe: 3 months

Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI

Timeframe: 3 months

Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale

Timeframe: 3 months

Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale

Timeframe: 3 months