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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01733732
Eligibility Criteria:
Inclusion Criteria:
* Read, sign, and date the Informed Consent Document;
* Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
* Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
* Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
* History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
* Use of any concomitant topical ocular medications during the study period;
* Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
* Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
* Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01733732
Study Brief:
Protocol Section:
NCT01733732