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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT04911361
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years and older
* Patients willing to take an electronic survey about their tolerability of either study medication.
* Patients with a recent exacerbation of dry eye characterized by ocular surface discomfort.
Exclusion Criteria:
* Active, systemic or local disease condition other than DES that causes clinically significant ocular surface irritation that could interfere with the evaluation and treatment of dry eye.
* Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
* Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure)
* Clinically significant ocular trauma.
* Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
* Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
* Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
* Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
* Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
* Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
* Participation in this trial in the same patient's fellow eye.
* Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04911361
Study Brief:
Protocol Section:
NCT04911361