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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT03804502
Eligibility Criteria:
Inclusion Criteria:
* Previously enrolled in the TearCare arm of the TearCare Pilot Study
* Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
* TBUT of \<10 seconds in at least one eye
* Willing to comply with the study, procedures, and follow-up
* Willing and able to provide consent
Exclusion Criteria:
* Any active ocular or peri-ocular infection or inflammation
* Recurrent eye inflammation within the past 3 months
* Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
* Ocular surface abnormalities that may affect tear film distribution or treatment
* Abnormal eyelid function in either eye
* Diminished or abnormal facial, periocular, ocular or corneal sensation
* Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
* Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
* Allergies to silicone tissue adhesives
* An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
* Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
* Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
* Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
* Participation in another ophthalmic clinical trial within the past 30 days
* Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03804502
Study Brief:
Protocol Section:
NCT03804502