NCT06903611

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

CAMOMILE-3: Phase III Randomized, Double-Masked, Safety and Efficacy Study of Topical Fibrinogen-Depleted Human Platelet Lysate Compared to Vehicle Control for the Treatment of Moderate to Severe Dry Eye

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Cambium Bio Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of this study is to evaluate the safety and efficacy of CAM-101 (FD hPL 30% v/v) topical ophthalmic solution after 9 weeks of treatment for moderate to severe dry eye disease and to evaluate the safety of CAM-101 (FD hPL 30%v/v) after 52-weeks of consecutive use

Conditions

• Dry Eye Disease
• Dry Eye
• Dry Eyes Chronic
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	CAM-101	fibrinogen depleted human platelet lysate
OTHER	Vehicle Control	Plasmalyte-A

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-11-01
• Completion: 2027-12-01
• First posted: 2025-03-31
• Last updated: 2025-05-18

Regulatory

• FDA-regulated drug study