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

NCT06903611 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CAM-101-003
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye Disease; Dry Eye; Dry Eyes Chronic; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  9 weeks

Study Arms (2)

1-Vehicle Control Group

PLACEBO COMPARATOR

Vehicle Control Group - masked treatment with vehicle control for 9 weeks. Instill 1 drop in both eyes 4 times per day for 9 weeks.

Other: Vehicle Control

2-Active Treatment Group

EXPERIMENTAL

CAM-101 Active Group - masked treatment with CAM-101 for 9 weeks; Instill 1 drop in both eyes 4 times per day for 9 weeks. Open label use long term follow up: CAM-101, install 1 drop in both eyes 4 times per day for 43 weeks if the patient was on active IP during the 9 week randomized study or 52 weeks if the patient was on vehicle during the 9 week randomized study

Drug: CAM-101

Interventions

CAM-101 DRUG

fibrinogen depleted human platelet lysate

Also known as: Elate Ocular, FD hPL

2-Active Treatment Group

Vehicle Control OTHER

Plasmalyte-A

Also known as: Placebo

1-Vehicle Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.; 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 :
• 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:

• 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

Sponsors & Collaborators

• Cambium Bio Limited: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Neera Jagirdar, MD MPH

  Cambium Bio Limited

  STUDY DIRECTOR

Central Study Contacts

VP, Medical, Clinical & Regulatory Affairs

CONTACT

6175929138; njagirdar@cambium.bio

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Masked Placebo Controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CAM-101 or vehicle control (per randomization), instill 1 drop in both eyes 4 times per day for 9 weeks. Open label use long term follow up: CAM-101, install 1 drop in both eyes 4 times per day for 43 weeks if the patient was on active IP during the 9 week randomized study or 52 weeks if the patient was on vehicle during the 9 week randomized study

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: March 31, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-03