Not Yet RecruitingPhase 3

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

400 participantsStarted 2025-09-30

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 range18 Years

SexALL

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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.; or 20 years of age or older if participating at a study site located in India.
✓. 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≥ 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.
✕. Using any topical ocular treatment other than the following medications:
✕. 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

What they're measuring

Corneal Fluorescein

Timeframe: 9 weeks

Eye Discomfort

Timeframe: 9 weeks

Trial details

NCT IDNCT06903611

SponsorCambium Bio Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

VP, Medical, Clinical & Regulatory Affairs

6175929138 njagirdar@cambium.bio

View on ClinicalTrials.gov More Dry Eye Disease trials