A Study To Investigate The Effects Of A Low Humidity Environment And Visual Tasking On Tear Film Protein Composition

NCT02005874 | Completed

• 2 other identifiers: 13-RD-01EGP #445977-12
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Clinical and Subjective Sign and 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

• Clinical and Subjective Sign and Symptom Scores

  Measured at time 0, and 60 min after exiting the EEC

• Clinical and Subjective Sign and Symptom Scores

  Measured at time 0, and 60 min after exiting the EEC

• Clinical and Subjective Sign and 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

• Clinical and Subjective Sign and Symptom Scores

  Measured at time 0, and 60 min after exiting the EEC

Other Outcomes (1)

• Exploratory Outcome Measure of MCFB tear osmolarity

  time 0, at 180 min after entry to the EEC and 60 min post exit.

Study Arms (2)

Dry eye

Non-dry eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 16 healthy adult volunteers (male or female), aged 18 and older, of which 50% must have signs and symptoms of mild-moderate dry eye syndrome.

You may qualify if:

• Male or female, aged 18 or older in good general health on the basis of medical history and ophthalmic examination
• Subjects must have no known systemic disease or need for medication which may interfere with the study
• 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.
• Subjects must have visual acuity best corrected to 20/50 or better for each eye with optometrist discretion for subjects with amblyopia.
• 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.
• Ability to comply with study protocol, provide written consent and complete study
• OSDI questionnaire score of ≥15
• Ocular dryness score of \>1 (0-4)
• TBUT \<7 sec
• 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
• OSDI questionnaire score \<15
• TBUT ≥7 sec
• Biomicroscopic assessment reveals no SPK and good tear meniscus
• Ocular dryness score of 0 (0-4)

You may not qualify if:

• Any ocular disease including keratoconus and Sjogren's syndrome
• Any tarsal abnormalities or corneal neovascularization \>Grade2
• Ocular surgery including refractive surgery within the last 12 months
• Intraocular Pressure (IOP)\>23mmHg and utilization of any prescribed ophthalmic medication
• 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.
• 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.
• 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)
• Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry.
• A known or suspected hypersensitivity, and/or contraindication to any of the ingredients of the investigational products.
• Not meeting concomitant medication washouts
• Inability to discontinue any ophthalmic eyedrops including OTC therapies.

Sponsors & Collaborators

• Inflamax Research Incorporated: lead

Study Sites (1)

Inflamax Research Incorporated

Mississauga, Ontario, L4W 1A4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA (Tears) - samples retained, with no intention for extraction of DNA but rather protein and cytokine analysis will be conducted from the tear collection

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

CA (1)