Phase III Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Placebo for Mode… (NCT06903611) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Placebo for Moderate to Severe Dry Eye
475 participantsStarted 2026-10-01
Plain-language summary
Prospective, multicenter, randomized, vehicle-controlled, double-masked, study of CAM-101 topical ophthalmic solution compared to vehicle control followed by crossover to long-term follow-up open-label treatment with CAM-101 for one year.
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 subjects who at the time of consent are 18 years of age or older, if participating at a study site located in the U.S.
. Having a self-reported history of dry eye disease within the past 6 months.
. NEI Corneal Fluorescein Staining Score in at least one eye at screening and at Day 0 (pre-randomization) that is ≥ 6 (total score)as determined by the investigator.
. Visual Analog Scale (VAS) Symptom Index-Eye Dryness/Eye Discomfort total score (pre-dose) that is ≥ 40 points at screening and at Day 0 (pre-randomization).
. Willingness to have both the right and left eyes treated in the study.
. Willingness to discontinue contact lenses and all current DED treatments except artificial tears.
. Be able to demonstrate ability to use study medication bottle; this can be documented on study bottle used during washout period.
. Female subjects must be either: (1) of non-childbearing potential; or, (2) of childbearing potential and using an acceptable method of birth control with a negative pregnancy test :
Exclusion criteria
. Any abnormal lid anatomy or blinking function in either eye.
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.
1This trial is testing a topical fibrinogen-depleted human platelet lysate — can you explain what that substance actually is, where it comes from, and what we currently know about its safety profile compared to the eye drops I might already be using?
2Since this is a Phase III trial, it's one of the later stages of testing — does that mean there's already enough earlier-phase data for you to feel confident about how safe and potentially effective this treatment might be for someone with my level of dry eye severity?
3The trial measures improvement using corneal fluorescein staining and eye discomfort scores — based on how my eyes look right now, do you think my condition would even show meaningful change on those specific measures, and does that affect whether this trial might be a good fit to discuss?
4This trial isn't recruiting yet — given that timing, should I be pursuing one of the currently available prescription treatments for moderate to severe dry eye now, and could starting those affect whether I'd be eligible to consider this trial later?
5Because this is a placebo-controlled study, there's a chance I could be assigned to the placebo group — how would that affect my care during the trial, and would I still have access to my current dry eye treatments if my symptoms got worse?
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.