Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT03286166
Eligibility Criteria:
Inclusion Criteria:
* 1\) Able to read, understand and sign an Informed Consent (IC) form 2) 22-85 years of age 3) Able and willing to comply with the treatment/follow-up schedule and requirements 4) Tear break up time of less than 10 seconds in both eyes 5) SPK in the conjunctiva and/or cornea of each eye 6) Eye dryness scale of 40 or greater at baseline for each eye 7) Self- reported ocular pain from dry eye disease
Exclusion Criteria:
1\) Unwilling to discontinue use of contact lenses for the duration of the study 2) Ocular surgery or eyelid surgery, within 3 months prior to screening 3) Neuro-paralysis in the planned treatment area, within 6 months prior to screening 4) Other uncontrolled eye disorders affecting the ocular surface, for example active allergies 5) Punctal plugs placed within past 90 days 6) Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area 7) Uncontrolled infections or uncontrolled immunosuppressive diseases 8) Subjects with current ocular infections. 9) New prescription eye drops for dry eye or glaucoma or omega 3 supplements prescribed within 90 days prior to screening, excluding artificial tears 10) New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management 11) Change in dosage of any systemic medication, within 3 months prior to screening 12) Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period 13) Legally blind in one or both eyes 14) First IPL treatment, within 3 months prior to screening 15) Any condition revealed during the eligibility screening process whereby the investigator deems the subject inappropriate for this study
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT03286166
Study Brief:
Protocol Section:
NCT03286166