Evaluation of Dry Eye by Tear Film Imager in a Low Humidity Environmental Exposure Chamber (TFI-LH16)

NCT03061578 | Completed

• 1 other identifier: TFI-A2-LH-EEC-16
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The study consists of 3 study visits to the clinic over at least 9 days. Visit 1 - the medical screening visit: subjects will undergo informed consent and will be tested for signs and symptoms of Dry Eye Syndrome (DES) including measurements by the TFI. Upon conclusion of the screening for DES, the subjects will be divided to the different categories: NDE, LDDE and ADDE. For ADDE and LDDE subjects the eye fitting the worst DES inclusion criteria will be designated as the study eye. For the NDE subjects the best eye will be designated as the study eye. During Visit 2 and 3, the TFI measurement and other clinical study endpoint procedures will be only conducted on the study eye. The safety endpoint procedures will still be conducted on both eyes individually throughout the study. Subjects will be queried for adverse events (AEs) at all visits. Visit 2 - after two days washout period subject will return for the LH-EEC test. Signs and symptoms of dry eye will be recorded before entering the LH-EEC, during the 120 min stay in the LH-EEC and at the conclusion of the day. Visit 3 - after 7 days washout period subject will return for the last test. The third day procedure is identical to the second day, with the addition of: following LH-EEC exit, subjects will have a health check and study check out procedures conducted. Statistical Analysis: Data will be summarized with respect to baseline characteristics, efficacy variables and safety variables. Summary statistics will include the number of observations (N), mean, standard deviation (SD), median, minimum and maximum values for continuous variables and frequencies and percentages for categorical variables. Missing values will not be replaced or imputed, i.e., no interpolation or extrapolation will be applied to missing values. Safety data will be listed and summarized by group (NDE, ADDE, and LDDE).

Conditions

Dry Eye

Keywords

Tear Film; Hyperspectral imaging; Low Humidity Environmental Exposure Chamber

Outcome Measures

Primary Outcomes (3)

• To compare the clinical measurements of DES to the TFI measurements

  The correlation between the clinical measurements of DES and the corresponding TFI measurement of interest will evaluate the association between the two assessments.

  Change from baseline to 120 minutes in the LH-EEC

• To evaluate the repeatability of the TFI

  The repeatability of the TFI will be evaluated from summary of TFI assessments between Visit 2 and Visit 3. The sensitivity of the imager to detect changes in ocular surface integrity will be evaluated from the summary of baseline to post baseline assessment scores by time points and visit.

  Change from baseline after 30 minutes

• To evaluate the ability of the TFI to detect changes in ocular surface integrity during and after desiccation in a LH-EEC model.

  The sensitivity of the imager to detect changes in ocular surface integrity will be valuated from the summary of baseline to post baseline assessment scores by time points and visit.

  Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+5 min) after start of exposure to LH-EEC

Secondary Outcomes (14)

• TFI lipid layer thickness (LLT)

  Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+5 min) after start of exposure to LH-EEC

• TFI aqueous layer thickness (ALT)

  Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+5 min) after start of exposure to LH-EEC

• Schirmer's Test score

  Change from baseline to 120 minutes in the LH-EEC

• Tear Break Up time (TBUT)

  Change from baseline to 120 minutes in the LH-EEC

• TFI lipid break up time (LBUT)

  Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+5 min) after start of exposure to LH-EEC

Other Outcomes (1)

• Safety Analysis

  At the study check out at the end of visit 3.

Study Arms (3)

NDE

Non Dry Eye (NDE) group will be used as control for DES diagnosis. Subjects in the non-dry eye criteria must meet all of the following criteria: 1. Have a Schirmer's Test (without anesthesia) of ≥10mm/5min in both eyes 2. OSDI questionnaire score \<13. 3. Fluorescein TBUT \> 7 s in both eyes. 4. CFS of 0 in all areas in both eyes. The NDE group will undergo the same diagnosis including Tear Film Imager diagnostic and Low Humidity Environmental Exposure Chamber (LH-EEC) stimulation as any other group of patients.

Diagnostic Test: Tear Film Imager; Diagnostic Test: Low Humidity Environmental Exposure Chamber (LH-EEC)

ADDE

Aqueous Deficiency Dry Eye (ADDE) group will be define by commonly known signs and symptoms. In order to classify subjects to the moderate to severe ADDE group, subjects must meet a predefined medical condition (Rheumatoid Arthritis, Dermatomyositis, Lupus or Sjögren's syndrome) and meet at least one of the following conditions: 1. Have a Schirmer's Test (without anesthesia) of ≤5mm/5min in either eye 2. Mean CFS of ≥1 in either eye. 3. Fluorescein TBUT ≤5 s in either eye. 4. OSDI questionnaire score ≥20 The ADDE group will undergo the same diagnosis including Tear Film Imager diagnostic and Low Humidity Environmental Exposure Chamber (LH-EEC) stimulation as any other group of patients.

Diagnostic Test: Tear Film Imager; Diagnostic Test: Low Humidity Environmental Exposure Chamber (LH-EEC)

LDDE

Lipid Deficiency Dry Eye (LDDE) group will be define by commonly known signs and symptoms. In order to classify subjects to the moderate to severe LDDE group, subjects must have moderate to severe Meibomian Gland Dysfunction (MGD score of 3-6) and meet at least one of the following conditions: 1. Have a Schirmer's Test (without anesthesia) of ≤5mm/5min in either eye 2. Mean CFS of ≥1 in either eye. 3. Fluorescein TBUT ≤5 s in either eye. 4. OSDI questionnaire score ≥20 The LDDE group will undergo the same diagnosis including Tear Film Imager diagnostic and Low Humidity Environmental Exposure Chamber (LH-EEC) stimulation as any other group of patients.

Diagnostic Test: Tear Film Imager; Diagnostic Test: Low Humidity Environmental Exposure Chamber (LH-EEC)

Interventions

Tear Film Imager DIAGNOSTIC_TEST

Ocular surface imaging assessment by the Tear Film Imager (TFI)

ADDE; LDDE; NDE

Low Humidity Environmental Exposure Chamber (LH-EEC) DIAGNOSTIC_TEST

Subjects will enter the LH-EEC (\<15% relative humidity (RH), temperature 22±5ºC, and 5±3ft/s directed air flow velocity) and remain for approximately 120 min.

ADDE; LDDE; NDE

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female volunteers, aged 18 years or older, either without or with DES (aqueous and lipid deficient).

You may qualify if:

• Male or female, aged 18 or older in good general health on the basis of medical history and ophthalmic examination.
• Confirmed absence of pregnancy according to a urine pregnancy test at screening (Visit 1) for WOCBP. WOCBP must agree to use effective methods of birth control during the study such as:
• Oral, transdermal, injectable, vaginal ring, implantable contraceptives, intrauterine devices, or intrauterine system starting/placement at least 4 weeks prior to Screening (Visit 1)
• Double barrier methods (diaphragm, cervical/vault cap, condom, contraceptive sponge plus a spermicide)
• Having a sterile partner (vasectomized \> 90 days prior to Screening Visit 1 )
• Practicing abstinence
• Non-heterosexual lifestyle
• 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 VA best corrected to 20/50 or better for each eye (with Investigator 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 the study protocol, provide written consent and complete the study.

You may not qualify if:

• Any ocular disease including keratoconus or nystagmus.
• Any tarsal abnormalities or corneal neovascularization \> Grade 2 (see Appendix 3).
• Ocular surgery including refractive surgery within the last 12 months.
• IOP \>25 mmHg and utilization of any prescribed ophthalmic medication.
• Subjects who fit the criteria for both ADDE and LDDE.
• 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 SLE 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 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.
• Current participation in another clinical study involving an experimental product, or participation in such a study within 30 days prior to study entry.
• Not meeting concomitant medication washouts.
• Inability to discontinue any ophthalmic eye drops including over the counter (OTC) therapies.
• Be an employee of the site that is directly involved in the management, administration, or support of this study or be an immediate family member of the same.

Sponsors & Collaborators

• Adom Advanced Optical Technologies Ltd.: lead
• Inflamax Research Incorporated: collaborator

Study Sites (1)

Inflamax Research Inc.

Mississauga, Ontario, L4W 1A4, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Peter Couroux, MD

  Inflamax Research Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: January 26, 2017
• Primary Completion: March 11, 2017
• Study Completion: May 11, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)