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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE BALANCE | Experimental | SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month |
|
| Minims Saline | Active Comparator | Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTANE® BALANCE eyedrops | Other |
| ||
| Minims® Saline 0.9% eyedrops |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Guillon, PhD, FCOptom, FAAO, CCTI | OTG Research & Consultancy | Principal Investigator |
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A total of 91 participants were enrolled and randomized. This reporting group includes all randomized participants (91).
Participants were recruited from 1 clinical site located in the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | SYSTANE BALANCE | One drop 4 times a day for a continuous period of 1 month |
| FG001 | Minims Saline | One drop 4 times a day for a continuous period of 1 month |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | SYSTANE BALANCE | One drop 4 times a day for a continuous period of 1 month |
| BG001 | Minims Saline | One drop 4 times a day for a continuous period of 1 month |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. | Posted | Mean | Standard Deviation | percentage of staining | Month 1 |
|
Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SYSTANE BALANCE | One drop 4 times a day for a continuous period of 1 month |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood poisoning | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abayomi Ogundele, Global Brand Medical Affairs Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| Other |
|
| Month 1 |
| 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. | Month 1 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One drop 4 times a day for a continuous period of 1 month
|
|
| 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. | This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. | Posted | Mean | Standard Deviation | logMAR | Month 1 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | Month 1 |
|
|
|
| 1 |
| 46 |
| 0 |
| 46 |
| EG001 | Minims Saline | One drop 4 times a day for a continuous period of 1 month | 1 | 45 | 0 | 45 |
| Knee operation | Surgical and medical procedures | MedDRA (15.1) | Non-systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| 90 minutes |
|
| 120 minutes |
|
| 60 minutes (n=44,43) |
|
| 90 minutes (n=44,43) |
|
| 120 minutes (n=44,43) |
|