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

NCT03061578 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2017-07-02

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Tear Film Imager

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

DIAGNOSTIC_TEST

Low Humidity Environmental Exposure Chamber (LH-EEC)

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.

Sponsors & Collaborators

  • Inflamax Research Incorporated

    collaborator INDUSTRY

  • Adom Advanced Optical Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Peter Couroux, MD · Inflamax Research Incorporated

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-26
Primary Completion
2017-03-11
Completion
2017-05-11

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061578 on ClinicalTrials.gov