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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01468168
Eligibility Criteria:
Inclusion Criteria:
* Individuals considered for entry into the study will be of either sex and any race who have:
* a confirmed diagnosis of dry eye,
* are willing to use no ocular treatments during the study other than study medication,
* have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
* will not use contact lenses during the study,
* Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
* 18 years of age or older,
* able to understand and provide written informed consent
Exclusion Criteria:
* Subjects with any of the following are not eligible to participate in the study:
* Fluorescein corneal staining or conjunctival staining that is too severe
* Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
* Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
* Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
* Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
* Ocular(including lid)disease/abnormality that may interfere with the study
* Corneal transplant in either eye, at any time prior to enrollment in the study
* Laser refractive surgery less than one year prior to Visit 1 (Day 1)
* Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
* Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
* Known allergy or sensitivity to any of the study medication components
* Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
* A woman who is pregnant, nursing, or planning a pregnancy
* Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01468168
Study Brief:
Protocol Section:
NCT01468168