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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT02597803
Eligibility Criteria:
Inclusion Criteria:
* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye for at least 6 months
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
* Have a Schirmer's Test score of ≤10mm and ≥1mm
* Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds
* Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea
Exclusion Criteria:
* Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;
* Have an IOP \> 25 mmHg at Visit 1;
* Have any planned ocular and/or lid surgeries over the study period;
* Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
* Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
* Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02597803
Study Brief:
Protocol Section:
NCT02597803