Dry Eye Syndrome, Lipid Deficiency
Conditions
Keywords
Dry eye, Ocular surface, Vision complaint, Tear film stability, Time controlled functional visual acuity, Tear film kinetics
Brief summary
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
Interventions
OTHERSYSTANE® BALANCE eyedrops
OTHERMinims® Saline 0.9% eyedrops
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-contact lens wearer; * Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire; * Lipid deficiency; * Best visual acuity of 6/9 or better in each eye; * Willingness to adhere to the instructions set in the clinical protocol; * Signature of the subject informed consent form; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Use of systemic medication which might produce dry eye side effects; * Systemic disease which might produce dry eye side effects; * Active or recent ocular inflammation or infection; * Use of ocular medication; * Significant ocular anomaly; * Previous ocular surgery; * Previous use of Restasis; * Any medical condition that might be prejudicial to the study; * Pregnant or lactating; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Bulbar Conjunctival Staining | Month 1 | The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast logMAR Time Controlled Visual Acuity (TCVA) | Month 1 | TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity. |
| Non Invasive Tear Film Break-up-time (NIBUT) | Month 1 | NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort. |
Participant flow
Recruitment details
Participants were recruited from 1 clinical site located in the UK.
Pre-assignment details
A total of 91 participants were enrolled and randomized. This reporting group includes all randomized participants (91).
Participants by arm
| Arm | Count |
|---|---|
| SYSTANE BALANCE One drop 4 times a day for a continuous period of 1 month | 46 |
| Minims Saline One drop 4 times a day for a continuous period of 1 month | 45 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Relocated abroad | 0 | 1 |
Baseline characteristics
| Characteristic | SYSTANE BALANCE | Minims Saline | Total |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 16.51 | 44.6 years STANDARD_DEVIATION 14.84 | 45.7 years STANDARD_DEVIATION 15.66 |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 45 |
| serious Total, serious adverse events | 1 / 46 | 1 / 45 |
Outcome results
Primary
Mean Bulbar Conjunctival Staining
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Time frame: Month 1
Population: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE BALANCE | Mean Bulbar Conjunctival Staining | Right eye | 0.743 percentage of staining | Standard Deviation 1.685 |
| SYSTANE BALANCE | Mean Bulbar Conjunctival Staining | Left eye | 0.531 percentage of staining | Standard Deviation 1.056 |
| Minims Saline | Mean Bulbar Conjunctival Staining | Right eye | 0.442 percentage of staining | Standard Deviation 0.999 |
| Minims Saline | Mean Bulbar Conjunctival Staining | Left eye | 0.443 percentage of staining | Standard Deviation 1.404 |
Secondary
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Time frame: Month 1
Population: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE BALANCE | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | Baseline | 0.220 logMAR | Standard Deviation 1.105 |
| SYSTANE BALANCE | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 60 minutes | 0.206 logMAR | Standard Deviation 1.106 |
| SYSTANE BALANCE | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 90 minutes | 0.240 logMAR | Standard Deviation 1.124 |
| SYSTANE BALANCE | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 120 minutes | 0.293 logMAR | Standard Deviation 1.09 |
| Minims Saline | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 120 minutes | 0.206 logMAR | Standard Deviation 0.973 |
| Minims Saline | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | Baseline | 0.253 logMAR | Standard Deviation 0.1 |
| Minims Saline | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 90 minutes | 0.202 logMAR | Standard Deviation 0.826 |
| Minims Saline | High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 60 minutes | 0.295 logMAR | Standard Deviation 0.84 |
Secondary
Non Invasive Tear Film Break-up-time (NIBUT)
NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
Time frame: Month 1
Population: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE BALANCE | Non Invasive Tear Film Break-up-time (NIBUT) | 60 minutes (n=44,43) | 7.81 seconds | Standard Deviation 10.17 |
| SYSTANE BALANCE | Non Invasive Tear Film Break-up-time (NIBUT) | 90 minutes (n=44,43) | 8.41 seconds | Standard Deviation 9.55 |
| SYSTANE BALANCE | Non Invasive Tear Film Break-up-time (NIBUT) | 120 minutes (n=44,43) | 6.92 seconds | Standard Deviation 6.52 |
| SYSTANE BALANCE | Non Invasive Tear Film Break-up-time (NIBUT) | Baseline (n=44,44) | 9.39 seconds | Standard Deviation 7.68 |
| Minims Saline | Non Invasive Tear Film Break-up-time (NIBUT) | Baseline (n=44,44) | 7.47 seconds | Standard Deviation 7.38 |
| Minims Saline | Non Invasive Tear Film Break-up-time (NIBUT) | 120 minutes (n=44,43) | 7.26 seconds | Standard Deviation 6.71 |
| Minims Saline | Non Invasive Tear Film Break-up-time (NIBUT) | 90 minutes (n=44,43) | 7.59 seconds | Standard Deviation 9.64 |
| Minims Saline | Non Invasive Tear Film Break-up-time (NIBUT) | 60 minutes (n=44,43) | 8.74 seconds | Standard Deviation 10.42 |
| Minims Saline/Right Eye | Non Invasive Tear Film Break-up-time (NIBUT) | 120 minutes (n=44,43) | 8.63 seconds | Standard Deviation 10.08 |
| Minims Saline/Right Eye | Non Invasive Tear Film Break-up-time (NIBUT) | Baseline (n=44,44) | 9.53 seconds | Standard Deviation 13.19 |
| Minims Saline/Right Eye | Non Invasive Tear Film Break-up-time (NIBUT) | 90 minutes (n=44,43) | 7.31 seconds | Standard Deviation 8.33 |
| Minims Saline/Right Eye | Non Invasive Tear Film Break-up-time (NIBUT) | 60 minutes (n=44,43) | 8.17 seconds | Standard Deviation 10.45 |
| Minims Saline/Left Eye | Non Invasive Tear Film Break-up-time (NIBUT) | 90 minutes (n=44,43) | 6.97 seconds | Standard Deviation 5.39 |
| Minims Saline/Left Eye | Non Invasive Tear Film Break-up-time (NIBUT) | 60 minutes (n=44,43) | 6.96 seconds | Standard Deviation 6.16 |
| Minims Saline/Left Eye | Non Invasive Tear Film Break-up-time (NIBUT) | Baseline (n=44,44) | 7.66 seconds | Standard Deviation 8.32 |
| Minims Saline/Left Eye | Non Invasive Tear Film Break-up-time (NIBUT) | 120 minutes (n=44,43) | 6.16 seconds | Standard Deviation 6.59 |