Dry Eye Clinical Trial
Official title:
A Study To Investigate The Effects Of A Low Humidity Environment And Visual Tasking On Tear Film Protein Composition
Verified date | December 2013 |
Source | Inflamax Research Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
The purpose of the study is to collect valuable data on the role of controlled humidity, temperature, airflow, and visual tasking in altering the tear film protein composition. The results from this preliminary study will help to explore the role of tear film markers in inflammatory and disease conditions. This can also be extended to understand the role of the tear film in protecting the ocular surface when individuals are exposed to low humidity environments which may incite discomfort symptoms.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female, aged 18 or older in good general health on the basis of medical history and ophthalmic examination 2. Subjects must have no known systemic disease or need for medication which may interfere with the study 3. Subjects must have healthy eyes (no ophthalmic medication use nor current ocular infection) and concomitant medication may be permitted at the discretion of the investigator as long as there is no interference with study objectives or subject's safety. 4. Subjects must have visual acuity best corrected to 20/50 or better for each eye with optometrist discretion for subjects with amblyopia. 5. Subjects must be willing to discontinue their own contact lens wear for the period 7 days before Screening Visit 1 through to the end of the study. 6. Ability to comply with study protocol, provide written consent and complete study INCLUSION CRITERIA FOR THE MILD - MODERATE DRY EYE SUBJECTS WILL INCLUDE: 7. OSDI questionnaire score of =15 8. Ocular dryness score of >1 (0-4) 9. TBUT <7 sec 10. Biomicroscopic assessment of superficial punctate keratitis (SPK) of at least 1 in a scale of (0-4) indicative of dry eye syndrome over the 5 zone NEI cornea INCLUSION CRITERIA FOR THE NON-DRY EYE SUBJECTS WILL INCLUDE: 11. OSDI questionnaire score <15 12. TBUT =7 sec 13. Biomicroscopic assessment reveals no SPK and good tear meniscus 14. Ocular dryness score of 0 (0-4) Exclusion Criteria: 1. Any ocular disease including keratoconus and Sjogren's syndrome 2. Any tarsal abnormalities or corneal neovascularization >Grade2 3. Ocular surgery including refractive surgery within the last 12 months 4. Intraocular Pressure (IOP)>23mmHg and utilization of any prescribed ophthalmic medication 5. Clinically significant disease or abnormality which the investigator may judge unsafe to participate in the study and/or interfere with the outcome of the study, including clinically significant physical findings on slitlamp examination or fundus evaluation. 6. Pregnancy or breastfeeding, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period, or for 30 days following the study period. 7. Subjects who require the use of antihistamines, corticosteroids or anti-glaucoma medications on a regular basis and who are unwilling to discontinue the use of these medications for appropriate periods prior to the study visits. (Section 4.3 Table 1: Prohibited Medication) 8. Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. 9. A known or suspected hypersensitivity, and/or contraindication to any of the ingredients of the investigational products. 10. Not meeting concomitant medication washouts 11. Inability to discontinue any ophthalmic eyedrops including OTC therapies. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Inflamax Research Incorporated | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Inflamax Research Incorporated |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Outcome Measure of MCFB tear osmolarity | time 0, at 180 min after entry to the EEC and 60 min post exit. | No | |
Primary | Change in Tear Protein and/or Cytokine Composition | Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC | No | |
Secondary | Clinical and Subjective Sign and Symptom Scores | MCFB in total ocular symptom score (TOSS) | Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC | No |
Secondary | Clinical and Subjective Sign and Symptom Scores | MCFB in total corneal staining using fluorescein | Measured at time 0, and 60 min after exiting the EEC | No |
Secondary | Clinical and Subjective Sign and Symptom Scores | MCFB in total conjunctival staining using lissamine green | Measured at time 0, and 60 min after exiting the EEC | No |
Secondary | Clinical and Subjective Sign and Symptom Scores | MCFB in individual symptom scores | Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC | No |
Secondary | Clinical and Subjective Sign and Symptom Scores | MCFB in Tear film Break Up Time (TBUT) | Measured at time 0, and 60 min after exiting the EEC | No |
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