Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs.… (NCT03414645) | Clinical Trial Compass
CompletedPhase 1/2
Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease
United States64 participantsStarted 2018-05-01
Plain-language summary
The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD).
Who can participate
Age range
18 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
. Male or female patients, of age 18 years (inclusive) or older at the time of signing the ICF;
. Diagnosis of DED secondary to GvHD following allogeneic hematopoietic stem cell transplantation as determined by medical history
. For females:
. Be of non-child-bearing potential. Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening) and menopause will be confirmed by a plasma FSH level of \>40 IU/L) or
. Women of childbearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control plus a barrier method, double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing, and
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.
1Since this trial used a topical fibrinogen-depleted human platelet lysate eye drop — a blood-derived product — what kinds of ocular or systemic side effects were being watched for, and is there anything from the completed results my doctor thinks is relevant to my situation?
2This was a Phase 1/2 trial focused primarily on safety rather than proving the treatment works — does that mean the evidence on whether it actually helps dry eye from graft-versus-host disease is still limited, and should I consider other established treatments first?
3Since the trial is now completed, has the results data been published or shared anywhere, and would my doctor be able to review the findings to help me understand if this approach might be worth pursuing?
4Given that this treatment was specifically studied in people with dry eye caused by graft-versus-host disease, how does my doctor assess whether my particular case of GvHD-related dry eye is similar enough to the patients in this trial for the results to be meaningful for me?
5Are there currently any follow-on trials or clinical programs using this type of platelet lysate eye drop that I might be eligible to discuss with my care team, now that this study has wrapped up?
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
1
Number of Participants With Ocular Treatment-related Adverse Events as Assessed by CTCAE v4.0
Timeframe: 42 Days
2
Number of Participants With Systemic Treatment-related Adverse Events as Assessed by CTCAE v4.0
Timeframe: 42 Days
3
Number of Participants With Treatment-related Adverse Events as Assessed Change From Normal to Abnormal With Clinical Significance in Any Ocular Examination
. Women with a negative pregnancy test (β-hCG assay) in urine at screening and Day 1 predose;
. Schirmer tear test with anesthesia \<7 mm/5 min in at least one eye during screening;
. Willingness and and ability to undergo, and return for, all scheduled study-related visits through Follow-up;
Exclusion criteria
. Any abnormal lid anatomy or blinking function in either eye;
. Any history of other ocular disease requiring topical ocular treatment other than artificial tears and/or Restasis® (cyclosporine ophthalmic emulsion; Allergan Irvine, CA) or Xiidra® (lifitegrast, Shire, Lexington, MA). Patients currently using Restasis® or Xiidra® for conditions other than DED (e.g., allergies);
. Previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye;
. Any relevant ocular anomaly interfering with the ocular surface, including active ocular herpes simplex infection, recurrent corneal erosion, symptomatic epithelial basement membrane dystrophy, mucus fishing syndrome, giant papillary conjunctivitis, post-radiation keratitis, Stevens-Johnson syndrome, corneal ulcer, abnormalities of the nasolachrymal drainage system, chemical injury, destruction of the conjunctival goblet cells or scaring, diagnosed significant anterior blepharitis and/or progressive pterygium, or any other additional condition(s) associated with or causing dry eye;
. Presence or history of any ocular disorder or condition, including ocular surgery (including palpebral and cataract surgery, trauma), infection (viral, bacterial, fungal), disease or inflammation not associated with dry eye unless disorder or disease is:
. Stable for at least 3 months before the Screening Visit; and
. As determined by the Investigator not likely to impact or possibly interfere with the interpretation of study results.
. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye;