Dry Eyes, Glaucoma
Conditions
Brief summary
Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.
Interventions
DRUGRefresh Tears Lubricant Eye Drops (Allergan)
Eye drops QID for 1 month
Sponsors
Allergan
University of Waterloo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 17 years of age and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Is a current non-contact lens wearer. * Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent. * The glaucoma medication dosage and usage must have been the same for \>6 months. * Shows a minimum score of 2 (sometimes) on the SESOD questionnaire. * Distance VA of at least 20/40 in each eye with current spectacle correction.
Exclusion criteria
* Is participating in any concurrent clinical or research study; * Has any known active\* ocular disease and/or infection; except primary open angle glaucoma. * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Is pregnant, lactating or planning a pregnancy at the time of enrolment; * Has undergone refractive error surgery; * Is an employee of the Centre for Contact Lens Research; * Has taken part in another (pharmaceutical) research study within the last 30 days; * Is currently using artificial tears more than 3 times per day. * For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Staining | At baseline (dispensing visit) | Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence |
| Tear Break up Time With Fluorescein | At baseline (dispensing visit) | The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Score | At baseline (dispensing visit) | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Comfort | At baseline (dispensing visit) | Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) Artificial tears eye drops QID for 1 month
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion criteria | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Refresh Tears Lubricant Eye Drops (Allergan) |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 5 |
| Region of Enrollment Canada | 11 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence
Time frame: At baseline (dispensing visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Ocular Surface Staining | 1.65 units on a scale | Standard Deviation 0.8 |
Primary
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence
Time frame: After 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Ocular Surface Staining | 1.55 units on a scale | Standard Deviation 0.88 |
Primary
Ocular Surface Staining
Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence
Time frame: After 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Ocular Surface Staining | 1.29 units on a scale | Standard Deviation 0.89 |
Primary
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Time frame: After 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Tear Break up Time With Fluorescein | 3.41 seconds | Standard Deviation 2.29 |
Primary
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Time frame: After 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Tear Break up Time With Fluorescein | 4.01 seconds | Standard Deviation 2.76 |
Primary
Tear Break up Time With Fluorescein
The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
Time frame: At baseline (dispensing visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Tear Break up Time With Fluorescein | 2.88 seconds | Standard Deviation 2.01 |
Secondary
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).
Time frame: 1 month after using artificial tears
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Ocular Surface Disease Index (OSDI) Score | 15 units on a scale | Standard Deviation 13 |
Secondary
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Time frame: At baseline (dispensing visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Ocular Surface Disease Index (OSDI) Score | 25 units on a scale | Standard Deviation 16 |
Secondary
Ocular Surface Disease Index (OSDI) Score
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
Time frame: 1 week after using artificial tears
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Ocular Surface Disease Index (OSDI) Score | 18 units on a scale | Standard Deviation 11 |
Other Pre-specified
Subjective Ratings of Comfort
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)
Time frame: At baseline (dispensing visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Subjective Ratings of Comfort | 80 units on a scale | Standard Deviation 14 |
Other Pre-specified
Subjective Ratings of Comfort
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
Time frame: 1 week after using artificial tears
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Subjective Ratings of Comfort | 92 units on a scale | Standard Deviation 8 |
Other Pre-specified
Subjective Ratings of Comfort
Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)
Time frame: 1 month after using artificial tears
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Tears Lubricant Eye Drops (Allergan) | Subjective Ratings of Comfort | 92 units on a scale | Standard Deviation 7 |