Dry Eye, Dry Eye Disease, Dry Eyes Chronic, Dry Eye Syndromes
Conditions
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.
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
Interventions
DRUGCAM-101
fibrinogen depleted human platelet lysate
OTHERVehicle Control
Plasmalyte-A
Sponsors
Cambium Bio Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Masked Placebo Controlled
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Having a self-reported history of dry eye disease within the past 6 months. 3. 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. 4. 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). 5. Willingness to have both the right and left eyes treated in the study. 6. Willingness to discontinue contact lenses and all current DED treatments except artificial tears. 7. Be able to demonstrate ability to use study medication bottle; this can be documented on study bottle used during washout period. 8. 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 : 1. 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). 2. 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. 9. 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. 10. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations. \-
Exclusion criteria
* Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein | 9 weeks | • 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. |
| Eye Discomfort | 9 weeks | • 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. |
Contacts
CONTACTVP, Medical, Clinical & Regulatory Affairs
STUDY_DIRECTORNeera Jagirdar, MD MPH
Cambium Bio Limited
Outcome results
None listed