Phase III Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Placebo for Moderate to Severe Dry Eye
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCambium Bio Limited
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Any abnormal lid anatomy or blinking function in either eye.
Non-refractive laser eye surgery of any type in either eye performed more than 3 months before screening is permitted.
Refractive surgery in either eye performed more than 6 months before screening is permitted.
Cataract surgery in either eye performed more than 3 months before screening is permitted
Trial design
Treatments tested in this trial
- CAM-101
- Vehicle Control
Treatment groups
475 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov