Defining the Tear Film Proteome

Study ID
STU 032014-016

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Yesenia Leach
337/255-6349
yesenia.leach@utsouthwestern.edu

Principal Investigator
Danielle Robertson, O.D., Ph.D.

Summary

This is a single center clinical study to analyze the tear film proteome in normal tears and changes in response to use of topical ophthalmic medications. in the first arm of this study, we will use genetically related family members to assess the variability of mass spectrometric analysis of the tear film protein. Specifically, this study will be performed using monozygotic and dizygotic twins, which will allow for a robust analysis with a relatively small sample size, For this arm, healthy, non-fasted volunteers without preexisting ocular disease will be recruited. a total of approximately 20 subjects will be recruited for this study (5 sets of each type of twin). Dry eye testing, consisting of a brief slit lamp exam and routine tear testing (i.e.: Schirmer's test for aqueous tear production, tear break up time for tear film stability, fluorescein and lissamine green staining, and measurement of the inferior tear meniscus height) will be performed to evaluate for dry eye status. Dry eye status will only be assessed at the first clinical visit. Ten microliters of basal tear fluid will be collected from the lateral canthus using micro-capillary tubes and stored at -80[Degrees]C, until use. Repeat sample collections will be performed on three additional days for a total of 4 study visits. Tear collection will be performed between 7am-12 pm for each visit. Samples from both eyes at all visits will be pooled for each individual patient (for a total of 80ul of tear fluid from each subject). Samples will be subject to SDS-PaGe, stained with Coomassie blue, and sent to our campus proteomics facility for analysis.

in the second arm of this study, we will use up to 40 healthy volunteers to assess changes in the tear film proteome in response to chronic use of topical eye drops. approximately 10 patients per group, with a total of 4 groups, will be recruited. Group 1 will consist of patients using topical glaucoma medications containing the preservative benzalkonium chloride (BaK) for a period of at least 3 months or more. in Group 2, patients will be users of non-preserved topical glaucoma eye drops. Group 3 will consist of patients that use artificial tears without any preservatives or drugs. Group 4 will consist of normal health adults without any current or former history of chronic topical eye drop use. Dry eye testing, consisting of a brief slit lamp exam and routine tear testing (i.e.: Schirmer's test for aqueous tear production, tear break up time for tear film stability, fluorescein and lissamine green staining, and measurement of the inferior tear meniscus height) will be performed to evaluate for dry eye status. Dry eye status will only be assessed at the first clinical visit. Ten microliters of basal tear fluid will be collected from the lateral canthus using micro-capillary tubes and stored at -80[Degrees]C, until use. Repeat sample collections will be performed on two additional days for a total of 3 study visits. Tear collection will be performed between 7am-12 pm for each visit. Samples from both eyes at all visits will be pooled for each individual patient (for a total of 60ul of tear fluid from each subject). Patient samples within each of the four groups will be pooled at each visit so that repeatability can be assessed across visits (visit 1 compared to visit 2 compared to visit 3). Samples will be subject to SDS-PaGe, stained with Coomassie blue, and sent to our campus proteomics facility for analysis.

Participant Eligibility

1. Healthy non-smoking patients without any current or former history of chronic topical eye drop use and without any ocular or systemic complications, with the exception of hypertension and high cholesterol
2. Non-contact lens wearers (or no past history of contact lens wear for 30 days prior to the visit) for patients of any race or origin,
3. Genetically related family members who are monozygotic and dizygotic twins ages 10 and up
4. Patients that are willing to review, understand, and sign the written Informed Consent
5. Written authorization for use or release of health and research study information
6. Patients that are willing and able to cooperate with the Investigator and follow all instructions
For subjects in arm 2 of the study, the above criteria hold ( with the exception of #3) in addition to the following:
7. Patients using topical glaucoma medications containing the preservative benzalkonium chloride (BAK) for a period of at least 3 months or more
8. Patients that use artificial tears without any preservatives or drugs
9. . Group 1 will consist of patients using topical glaucoma medications containing the preservative benzalkonium chloride (BAK) for a period of at least 3 months or more.
10. In Group 2, patients will be users of non-preserved topical glaucoma eye drops.
11. Group 3 will consist of patients that use artificial tears without any preservatives or drugs.
12. Group 4 will consist of normal health adults without any current or former history of chronic topical eye drop use.