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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT01102257
Eligibility Criteria:
Inclusion Criteria:
1. Sign and date the informed consent form approved by the IRB.
2. ≥ 18 years of age
3. Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization).
1. Conjunctival staining present ≥ 1
2. Corneal fluorescein staining present ≥ 1
3. Tear film break up time (TFBUT) ≤ 7 seconds
4. Schirmer test ≤ 7 mm/5min
4. Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
5. Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months.
6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.
7. Women of child-bearing potential must agree to use a reliable method of contraception during study participation, and must demonstrate a negative urine pregnancy test at screening visit.
8. Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
9. Be able to swallow large, soft gelcaps
Exclusion Criteria:
1. Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
2. Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
3. History of ocular herpetic keratitis.
4. Eye surgery (including cataract surgery) within 6 months prior to randomization.
5. Previous LASIK surgery
6. Pregnant or nursing/lactating
7. Participation in a study of an investigational drug or device within the past 30 days.
8. Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation
9. Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
10. Contact lens wearers
11. Use of glaucoma medication or history of surgery for glaucoma.
12. Recent (≤ 3 months) insertion of punctual plugs.
13. Using punctual plugs but unwilling to commit to their use for the duration of the study.
14. Unwilling to commit to same brand of artificial tears throughout the study.
15. Current use of EPA/DHA supplements in excess of 1 gram/day.
16. Recent (≤ 6 months) initiation of use of Restasis.
17. Use of Restasis but unwilling to commit to use of Restasis for the duration of the study.
18. Discontinued use of Restasis within the last 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01102257
Study Brief:
Protocol Section:
NCT01102257