Dry Eye Syndrome
Conditions
Brief summary
The main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.
Interventions
DEVICECarboxymethylcellulose sodium, glycerin and polysorbate 80
1 drop in each eye three times a day for a period of 30 (± 4) days
Sponsors
Allergan
Optometric Technology Group Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild or greater dry eye symptoms. * Evidence of evaporative dry eye
Exclusion criteria
* Known allergy or sensitivity to the study product(s) or its components * Current contact lens wearer * Systemic or ocular allergies * Use of systemic medication which might have ocular side effects. * Any ocular infection. * Use of ocular medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Evaporation Rate | after 30 days of eyedrop usage | The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10\^-7 g/cm\^2 /s and recorded for relative humidity of 25% to 35%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break Up Time | after 30 days of eyedrop usage | The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis. |
| Ocular Surface Disease Index Score | after 30 days of eye drop usage | The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function. The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability. |
Countries
United Kingdom
Participant flow
Recruitment details
The subjects were selected from the existing clinical population of Optometric Technology Group Ltd (OTG Research & Consultancy). The subjects, fulfilling the criteria for inclusion were invited in a random fashion to participate in the study until the test population was achieved.
Participants by arm
| Arm | Count |
|---|---|
| Investigational Eye Drop Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Investigational Eye Drop |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 49 years STANDARD_DEVIATION 16 |
| Region of Enrollment United Kingdom | 35 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Tear Film Evaporation Rate
The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10\^-7 g/cm\^2 /s and recorded for relative humidity of 25% to 35%.
Time frame: after 30 days of eyedrop usage
Population: The analysis was carried out on subjects having completed the study according to the protocol e.g. 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Eye Drop | Tear Film Evaporation Rate | 26.0 10^-7g/cm^2/sec | Standard Deviation 11.2 |
Secondary
Ocular Surface Disease Index Score
The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function. The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability.
Time frame: after 30 days of eye drop usage
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Eye Drop | Ocular Surface Disease Index Score | 26.8 points | Standard Deviation 23 |
Secondary
Tear Break Up Time
The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.
Time frame: after 30 days of eyedrop usage
Population: The analysis was carried out on subjects having completed the study according to the protocol e.g. 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Eye Drop | Tear Break Up Time | 5.8 seconds | Standard Deviation 4.3 |