Phase III Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Placebo for Moderate to Severe Dry Eye

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease, Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes

In brief

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.

Key facts

Study ID

NCT06903611

Run by

Cambium Bio Limited

People needed

475

Starts

2026-10-01

Expected to finish

2028-12-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 :
• Females of Non-childbearing Potential: Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) prior to screening; or, post-menopausal (i.e., no menstrual bleeding for at least 1 year prior to screening; or with a negative pregnancy test if less than 1 year post-menopausal).
• Females of Childbearing Potential: Must agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control, or double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing.
• Providing written Informed Consent consistent with privacy language as per national regulations (e.g., HIPAA authorization) with signature obtained from the subject or legally authorized representative prior to the performance of any study related procedures (including withdrawal of prohibited medication.
• Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria for one or both eyes at screening will not be enrolled in the study. Subjects who meet any of the following exclusion criteria for one or both eyes on Day 0 will not be randomized and will be withdrawn from the study as screen failures:
• Any abnormal lid anatomy or blinking function in either eye.
• Using any topical ocular treatment other than the following medications:
• a. Artificial Tears: Preservative-free artificial tears may be used as needed before and/or during the study. Whenever practicable, the same brand of artificial tears should be used throughout the study and its use documented in the patient diary throughout study participation.
• Previous ocular surgery of any type (including lacrimal, corneal and trauma), except:
• 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
• Any ocular anomaly that, in the investigator's opinion, interferes with the ocular surface, including:
• Active ocular herpes simplex virus 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 nasolacrimal drainage system
• Chemical injury
• Diagnosed significant anterior blepharitis and/or progressive pterygium
• Current history of ocular infection (viral, bacterial, fungal), disease or inflammation (e.g., uveitis) not associated with dry eye, unless the disorder or disease is, in the investigator's opinion:
• Stable for at least 3 months before the Screening Visit; and,
• Not likely to impact or possibly interfere with the interpretation of study results.
• Subjects with a current intraocular infection or with any other current eye or systemic condition (e.g., severe endothelial corneal dystrophy) that, in the investigator's opinion, would interfere with the dry eye evaluation or treatment, or for which the potential benefits of CAM-101 do not outweigh the risks.
• History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than that secondary to dry eye.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.