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 range18 Years – 99 Years

SexALL

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

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 range18 Years – 99 Years

SexALL

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