Dry Eye Disease (DED)
Conditions
Brief summary
Determine the effect of a single instillation of NOV03 on the thickness and evaporation rate of the mucus-aqueous layer of the tear film
Interventions
DRUGinstillation of NOV03
This trial consists of 2 office visits over a period of approximately 2 weeks. At Visit 2, a designated clinical staff member or the investigator will instill 1 drop of NOV03 into each eye.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This pilot, open label, single-arm, single-center study will consist of 2 study visits in subjects with dry eye disease associated with MGD. A Screening Visit will occur to verify subjects are eligible to participate followed by an Assessment Visit to evaluate tear film parameters at baseline and over approx. 4 hours following a single instillation of NOV03
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General/Ocular Inclusion Criteria 1\. Will be at least 18 years of age at the time of consent. 2. Able to provide written voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) ≤5 sec at Visit * Have Ocular Surface Disease Index (OSDI) ≥25 at Visit 1. * Have an unanesthetized Schirmer's Test I ≥5 mm at Visit 1. * Have Meibomian Gland Dysfunction (MGD) defined as total MGD score ≥ 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit 1. * Have a total corneal fluorescein staining score of ≥2 and ≤11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit 1. * Have at least one eye that satisfies all criteria for 4-8 above at Visit 1. * Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus * Is able and willing to follow instructions, including participation in all trial assessments and visits.
Exclusion criteria
General/Ocular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thickness of the Mucus-aqueous Tear Film Layer | over 4 hours following instillation of NOV03 | Thickness of the mucus-aqueous layer of the tear film, measured in nanometers |
| Thinning Rate of the Mucus-aqueous Tear Film Layer | over 4 hours following instillation of NOV03 | The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perfluorohexyloctane Instillation of NOV03: This trial consists of 2 office visits over a period of approximately 2 weeks. At Visit 2, a designated clinical staff member or the investigator will instill 1 drop of NOV03 into each eye. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Perfluorohexyloctane |
|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Thickness of the Mucus-aqueous Tear Film Layer
Thickness of the mucus-aqueous layer of the tear film, measured in nanometers
Time frame: over 4 hours following instillation of NOV03
Population: The study had substantial technical data collection issues that prevented many of the subjects' parameter scores from being saved and analyzed. For the mucus-aqueous layer thickness the number of study eyes for which measurements were collected ranged from 15-24 rather than the planned 30 study eyes. Analysis was conducted without imputation of data. Thus, results were inconclusive due to data collection issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perfluorohexyloctane | Thickness of the Mucus-aqueous Tear Film Layer | 3920.3 nm | Standard Deviation 797.7 |
Primary
Thinning Rate of the Mucus-aqueous Tear Film Layer
The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second
Time frame: over 4 hours following instillation of NOV03
Population: The study had substantial technical data collection issues that prevented many of the subjects' parameter scores from being saved and analyzed. For the mucus-aqueous layer thickness thinning rate (MALTR) the number of study eyes for which measurements were collected ranged from 6-11 rather than the planned 30 study eyes. Analysis was conducted without imputation of data. Thus, results were inconclusive due to data collection issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perfluorohexyloctane | Thinning Rate of the Mucus-aqueous Tear Film Layer | -62.3 nm/s | Standard Deviation 90.9 |