A Clinical Study to Evaluate Innovative Tear Film Imaging for the Evaluation of Dry Eye and Its Correlation to Traditional Signs and Symptoms of Dry Eye Syndrome in a Low Humidity Environmental Exposure Chamber (LH-EEC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- To evaluate the ability of the TFI to detect changes in ocular surface integrity during and after desiccation in a LH-EEC model.
研究概览
简要总结
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).
详细描述
This study consists of 3 study visits to the clinic (a medical screening visit, and 2 LH-EEC visits) over at least 9 days. Subjects need to refrain from putting on any makeup near their eyes on the morning of each visit.
At the medical screening visit (Visit 1), subjects will undergo informed consent, fill out the Ocular Surface Disease Index (OSDI) questionnaire, and provide medical/surgical/ocular/medication histories and demographics. A urine pregnancy test will be performed on women of childbearing potential (WOCBP). Prior to any baseline symptom or sign collection, subjects will be acclimatized to the clinic environment for at least 30 min. Baseline subject rating of ocular symptoms (dryness, burning/stinging, tearing, grittiness/sandiness, intermittent blurring, soreness/discomfort, sensitivity to light [photophobia]) in both eyes together will be recorded using the electronic Patient Data Acquisition Tablet (ePDAT™) on a 0-4 scale with 0.5 increments. To meet eligibility criteria, subjects will participate in the following ophthalmic examinations (in the order specified): distance visual acuity (VA), slit lamp examination (SLE), undilated fundus examination, non-contact tonometry (NCT) followed by at least a 30 min wait, baseline TFI ocular surface imaging assessment (duplicate measurements at least 30 min apart in both eyes), Tear Break Up Time (TBUT), corneal fluorescein staining (CFS), conjunctival lissamine green staining (CLGS), Schirmer's Test without anesthetic, and Meibomian Gland Dysfunction (MGD)testing. Upon conclusion of the screening for DES, 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 (i.e. TBUT, CFS, CLGS, Schirmer's Test) will be only conducted on the study eye, however the safety endpoint procedures (i.e. VA, SLE, undilated fundus exam NCT) will still be conducted on both eyes individually throughout the study. Subjects will be queried for adverse events (AEs) at all visits. The clinic environment will be monitored for relative humidity (%RH) and temperature (ºC) at each visit.
After at least a 2 day washout period, subjects will return to the clinic for Visit 2.
Prior to any baseline symptom or sign collection, subjects will be acclimatized to the clinic environment for at least 30 min. Subjects will be queried for changes in health and medication use since the last visit. Baseline subject rating of the 7 subjective ocular symptoms will be recorded using the ePDAT™. Baseline ophthalmic evaluations will be conducted (in the order specified) including VA, SLE followed by at least a 30 min wait, TFI assessment (single measurement only), TBUT, CFS, CLGS and Schirmer's Test without anesthetic. Following the Schirmer's Test, subjects will wait at least 60 min in the clinic and during this time, baseline blink rate (blink/min, in triplicate) will be measured. Subjects will then have a second TFI measurement and then enter the LH-EEC. Subject symptom scoring and staff assessed blink rate will be assessed on both eyes together throughout the study.
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. During this time subjects are asked to visually task on a digital screen to ensure the ocular surface is exposed to the airflow and humidity levels in the room. Environmental conditions in the LH-EEC, including relative humidity (%RH) and temperature (ºC), will be monitored. Subject-assessed symptoms will be assessed at 15, 30, 60, 90, and 120 min (+5 min), while in the LH-EEC. Blink rate and TFI tear film imaging assessment (single measurement on the study eye only) will be assessed by qualified staff at 35, 65, 95 min (+15 min), and prior to LH-EEC exit. After all other procedures and prior to exiting the chamber, VA, TBUT, CFS, CLGS, and Schirmer's Test without topical anesthetic, will be performed. After LH-EEC exit, a health check will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate the ability of the TFI to detect changes in ocular surface integrity during and after desiccation in a LH-EEC model.
时间窗: 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
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.
To compare the clinical measurements of DES to the TFI measurements
时间窗: Change from baseline to 120 minutes in the LH-EEC
The correlation between the clinical measurements of DES and the corresponding TFI measurement of interest will evaluate the association between the two assessments.
To evaluate the repeatability of the TFI
时间窗: Change from baseline after 30 minutes
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.
次要结局
- Total CLGS(Change from baseline to 120 minutes in the LH-EEC)
- Total symptom score(Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+15 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)
- Ocular Surface Disease Index (OSDI)(At baseline)
- 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)
- Total CFS(Change from baseline to 120 minutes in the LH-EEC)
- Dryness symptom score(Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+15 min) after start of exposure to LH-EEC)
- Inter Blink Interval (IBI)(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 field of view(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 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)
- Schirmer's Test score(Change from baseline to 120 minutes in the LH-EEC)
- Blink rate(Change from baseline measurements prior to entering the LH-EEC and at 15, 30, 60, 90, and 120 min (+15 min) after start of exposure to LH-EEC)
- TFI resolution(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)