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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT00840268
Eligibility Criteria:
Inclusion Criteria:
* Must read, sign, and date an informed consent document and HIPAA privacy document.
* Diagnosis of dry eye at Visit 1 (Day 0).
* Able and willing to follow study instructions.
* Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
* History or evidence of ocular or intraocular surgery in either eye within the previous year.
* History or evidence of serious ocular trauma in either eye within the previous 6 months.
* History or evidence of corneal transplant or transplant variant procedures.
* History of intolerance or hypersensitivity to any component of the study medications.
* History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit 1.
* History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.
* Use of any concomitant topical ocular medications including artificial tears during the study period.
* Females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.
* Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit 1.
* Use of systemic medications that have not been stable for 30 days prior to Visit 1.
* Any ocular condition that may preclude the safe administration of the test article.
* Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.
* Use of punctal plugs or punctal cautery.
* Use of lid scrubs/warm compresses within 14 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00840268
Study Brief:
Protocol Section:
NCT00840268