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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00809003
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria (Sjogren's group)
A person is eligible for inclusion in the study, for the dry eye group, if she:
1. Has been diagnosed to have SS(confirmed via American-European Consensus Criteria 2002)and dry eye and half of the time wants to use eye drops for dry eye symptoms (dry eye group).
2. Has read, understood and signed an information consent letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Has had an ocular examination in the last two years.
Inclusion criteria (severe DE group)
A person is eligible for inclusion in the study, for the dry eye group, if he/she:
1. Has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the time wants to use eye drops for dry eye symptoms (dry eye group)
2. Has read, understood and signed an information consent letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Has had an ocular examination in the last two years.
Inclusion criteria (control group)
A person is eligible for inclusion in the study, for the control group, if he/she:
1. Has read, understood and signed an information consent letter.
2. Is willing and able to follow instructions and maintain the appointment schedule.
3. Has clear corneas and no active ocular disease.
4. Has had an ocular examination in the last two years.
Exclusion Criteria:
A person will be excluded from the study if he/she (Sjogren's group):
1. Is a contact lens wearer.
2. Has any clinically significant belpharitis.
3. Has undergone corneal refractive surgery.
4. Is aphakic.
5. Has any active ocular disease.
6. Is using any systemic or topical medications that may affect ocular health.
7. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
8. Is participating in any other type of clinical or research study.
A person will be excluded from the study if he/she (Dry eye group):
1. Is a contact lens wearer.
2. Has any clinically significant belpharitis.
3. Has undergone corneal refractive surgery.
4. Is aphakic.
5. Has any active ocular disease.
6. Is using any systemic or topical medications that may affect ocular health.
7. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
8. Is participating in any other type of clinical or research study.
A person will be excluded from the study if he/she (control group):
1. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.
2. Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuro-endocrine system function.
3. Has undergone corneal refractive surgery.
4. Is aphakic.
5. Has any active ocular disease.
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
7. Is participating in any other type of clinical or research study.
8. Is a contact lens wearer.
9. Has blepharitis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
70 Years
Study:
NCT00809003
Study Brief:
Protocol Section:
NCT00809003