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

ConditionsDry Eye Disease Dry Eye Dry Eyes Chronic Dry Eye Syndromes

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

CAM-101
Drug
fibrinogen depleted human platelet lysate
Vehicle Control
Other intervention
Plasmalyte-A

Treatment groups

475 Participants

are divided into 2 treatment groups

Group A: 1-Vehicle Control GroupPlacebo comparator 1 intervention

Group B: 2-Active Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Corneal Fluorescein

• Decrease in dry eye severity from baseline after 9 weeks of CAM-101 treatment (Corneal Fluorescein Staining Index (CFSi) Score; significance evaluated at p\<0.05 level); CFSi is a digital, objective, centesimal scoring system for measuring corneal fluorescein staining as an indicator of corneal surface integrity. The variability associated with the automated analysis of the corneal staining should be less than the subjective analysis of a two reader and an adjudicator model of subjectively assessing the corneal staining associated with the 4-point NEI scoring method. Corneal staining for each eye will be evaluated in each of the 5 segments for each eye. The evaluation will be scored from 0-3, where where Corneal Staining Score: 0 = none; 1 = mild; 2 = moderate; 3 = severe, and sum the total composite score for the 5 zones for each eye. Thus, each eye can have a score ranging from 0 to 15.

Time frame

9 weeks

Eye Discomfort

• Improvement in Eye Discomfort after 9 weeks of CAM-101 treatment (VAS Symptom Index Eye Dryness/Eye Discomfort); significance evaluated at p\<0.05 level); the VAS Eye Discomfort Score, is based on a continuous 100 point scale where 0 is no discomfort and 100 is intense discomfort.

Time frame

9 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cambium Bio Limited

Lead sponsor

Source ClinicalTrials.gov

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