Phase
Condition
Dry Eye Disease
Eyelid Inflammation
Sjogren's Syndrome
Treatment
Miebo
Saline
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be at least 18 years of age at the time of consent.
Have a self-reported history of DED in both eyes (OU) for at least 6 months prior toVisit 1 (Screening/Baseline)
Have a total corneal fluorescein staining score (tCFS) score >2 in both eyes
Have an Ocular Surface Disease Index (OSDI) score >17
Have a baseline ECD ≥1750 cells/mm2 in each eye
Provide written informed consent
Be able and willing to follow instructions, including participation in all trialassessments and visits
If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits
Exclusion
Exclusion Criteria:
Be at least 18 years of age at the time of consent.
Have a self-reported history of DED in both eyes (OU) for at least 6 months prior toVisit 1 (Screening/Baseline)
Have a total corneal fluorescein staining score (tCFS) score >2 in both eyes
Have an Ocular Surface Disease Index (OSDI) score >17
Have a baseline ECD ≥1750 cells/mm2 in each eye
Provide written informed consent
Be able and willing to follow instructions, including participation in all trialassessments and visits
If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits
Have any clinically significant ocular surface slit lamp findings and/or in theopinion of the Investigator have any findings that may interfere with trialparameters in either eye
Have an ocular or periocular malignancy in either eye
Have a history of herpetic keratitis in either eye
Have any planned ocular and/or lid surgeries in either eye during the course of thestudy
Have a known allergy and/or sensitivity to the IP
Have a history of ocular laser surgery in either eye within 3 months (90 days) priorto Visit 1 (Screening/Baseline)
Have a history of incisional ocular surgery or severe trauma in either eye within 3months (90 days) prior to Visit 1 (Screening/Baseline)
Have high contrast best-corrected visual acuity equal to or worse than logMAR +0.7 (Snellen equivalent score of 20/100 or worse) as assessed by Early TreatmentDiabetic Retinopathy Study (ETDRS) scale in either eye, obtained under bright roomlighting
Be a woman who is pregnant, nursing or planning a pregnancy during the course of thestudy
Be a woman of childbearing potential who is unwilling to submit to a urine pregnancytest. Non-childbearing potential is defined as a woman who is permanently sterilized (eg, has had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy)or is postmenopausal (without menses for 12 consecutive months).
Be a woman of childbearing potential who is not using an acceptable method of birthcontrol. Acceptable methods of contraception include hormonal - oral, implantable,injectable, or transdermal - contraceptives; mechanical contraception - spermicidein conjunction with a barrier such as a diaphragm or condom; intrauterine device; orsurgical sterilization of partner. For non-sexually active females, abstinence maybe regarded as an adequate method of birth control; however, the subject must agreeto use adequate birth control as defined above for the remainder of the study if shebecomes sexually active during the trial.
Be currently enrolled in an investigational drug or device trial or plan to enrollduring the course of the study
Have a condition or be in a situation that the Investigator believes may put thesubject at significant risk, may confound the study results, or may interferesignificantly with the subject's participation in the study
Study Design
Connect with a study center
Site 101
Glendale, California 91204
United StatesSite Not Available
Site 112
Murrieta, California 92562
United StatesSite Not Available
Site 102
Newport Beach, California 92663
United StatesSite Not Available
Site 109
Rancho Cordova, California 95670
United StatesSite Not Available
Site 111
Santa Ana, California 92705
United StatesSite Not Available
Site 106
Torrance, California 90505
United StatesSite Not Available
Site 113
Delray Beach, Florida 33484
United StatesSite Not Available
Site 107
Morrow, Georgia 30260
United StatesSite Not Available
Site 105
Carmel, Indiana 46290
United StatesSite Not Available
Site 110
Kansas City, Missouri 64111
United StatesSite Not Available
Site 104
Saint Louis, Missouri 63131
United StatesSite Not Available
Site 108
Asheville, North Carolina 28803
United StatesSite Not Available
Site 103
Memphis, Tennessee 38119
United StatesSite Not Available
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