Phase
Condition
Dry Eye Disease
Sjogren's Syndrome
Dry Eyes
Treatment
Vehicle Control
CAM-101
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects who at the time of consent are 18 years of age or older, ifparticipating at a study site located in the U.S.; or 20 years of age or older ifparticipating 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 exceptartificial tears.
Be able to demonstrate ability to use study medication bottle; this can bedocumented on study bottle used during washout period.
Female subjects must be either: (1) of non-childbearing potential; or, (2) ofchildbearing potential and using an acceptable method of birth control with anegative 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 anegative pregnancy test if less than 1 year post-menopausal).
Females of Childbearing Potential: Must agree to use a highly effectiveacceptable form of birth control (e.g., established hormonal birth control, ordouble barrier method: intrauterine device plus condom or spermicidal gel pluscondom) from 21 days prior to dosing until 7 days after dosing.
Providing written Informed Consent consistent with privacy language as per nationalregulations (e.g., HIPAA authorization) with signature obtained from the subject orlegally authorized representative prior to the performance of any study relatedprocedures (including withdrawal of prohibited medication.
Willingness and ability to comply with schedule for follow-up visits andpostoperative evaluations.
Exclusion
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria for one or both eyes atscreening will not be enrolled in the study. Subjects who meet any of the followingexclusion criteria for one or both eyes on Day 0 will not be randomized and will bewithdrawn from the study as screen failures:
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 neededbefore and/or during the study. Whenever practicable, the same brand ofartificial tears should be used throughout the study and its use documented inthe 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 morethan 3 months before screening is permitted.
Refractive surgery in either eye performed more than 6 months beforescreening is permitted.
Cataract surgery in either eye performed more than 3 months beforescreening is permitted
Any ocular anomaly that, in the investigator's opinion, interferes with theocular 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
Corneal ulcer
Abnormalities of the nasolacrimal drainage system
Chemical injury
Diagnosed significant anterior blepharitis and/or progressive pterygium
Current history of ocular infection (viral, bacterial, fungal), disease orinflammation (e.g., uveitis) not associated with dry eye, unless the disorderor disease is, in the investigator's opinion:
Stable for at least 3 months before the Screening Visit; and,
Not likely to impact or possibly interfere with the interpretation ofstudy results.
Subjects with a current intraocular infection or with any other current eye orsystemic condition (e.g., severe endothelial corneal dystrophy) that, in theinvestigator's opinion, would interfere with the dry eye evaluation ortreatment, or for which the potential benefits of CAM-101 do not outweigh therisks.
History of ocular allergy (including seasonal conjunctivitis) or chronicconjunctivitis other than that secondary to dry eye.
Known hypersensitivity to the components of CAM-101 or the vehicle control (fibrinogen-depleted human platelet lysate; Plasma-Lyte A).
Known hypersensitivity to one of the procedural medications (e.g.,proparacaine, fluorescein) unless a suitable alternative medication isavailable.
Inability to refrain from contact lens wear during the study, including thevehicle control run-in period.
Anticipated need for temporary or permanent punctum plugs during the study. (Ifpunctum plugs have been in place for at least 4 weeks prior to the screeningvisit, the plugs are allowed to remain in place during the study. ) Patientsmust remain symptomatic for DED post punctal plug insertion.
Any ocular disease or ocular condition not stabilized within 1 month (30 days)before the screening visit.
Any clinically significant systemic disease or condition that is inadequatelycontrolled (e.g., diabetes, thyroid disease, autoimmune disease) or notstabilized within 4 weeks before the screening visit.
Inability or unwillingness to discontinue use of autologous serum eye drops orplatelet rich plasma eye drops during the 2-week run-in period and throughoutthe remainder of the study.
Female subjects who are pregnant or lactating or plan to become pregnant duringthe course of the study.
Subjects not under legal guardianship who, in the investigator's opinion, lackthe mental capacity to provide written informed consent for studyparticipation.