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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01808560
Eligibility Criteria:
Inclusion Criteria:
* 55 to 85 years of age
* Must be able to comply with protocol including study randomization; completion of planned bilateral cataract surgery; no use of other MGD or dry eye treatments during the study; and attendance at all study visits
* Meibomian gland dysfunction in both eyes based on total meibomian gland score
* None to mild dry eye symptoms based on Ocular Surface Disease Index score
* Tear film interferometry assessment of 100 units or less
Exclusion Criteria:
* Systemic disease conditions that causes dry eye
* Use of systemic medications known to cause dry eye
* Use of other MGD or dry eye treatments except for over the counter lubricants or dietary supplements
* History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
* Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
* Participation in another ophthalmic drug or device trial in the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT01808560
Study Brief:
Protocol Section:
NCT01808560