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The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Ultra | Experimental | Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
|
| Optive | Active Comparator | OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative-free saline solution eyedrops | Other | 1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis. | Baseline, Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Burmaster | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27422973 | Derived | Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15. |
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Of the 105 enrolled, 11 subjects were exited prior to randomization: 9 screen failures, 1 adverse event, and 1 lost to follow-up. This reporting group includes all randomized subjects (94).
Subjects were recruited from 13 study centers located in France and 3 study centers located in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Systane Ultra | Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
| FG001 | Optive | Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I, Day 0 to Day 35 |
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| Phase II, Day 35 to Day 90 |
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This analysis group includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Systane Ultra | Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
| BG001 | Optive | Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
| Units | Counts |
|---|---|
| Participants |
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| 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 Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis. | This analysis group includes all randomized subjects with data at visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 35 |
|
Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
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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 | Pre-treatment | All subjects who consented to participate in the study prior to exposure to investigational product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Brand Med Affairs Lead, Pharma, GCRA | 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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| Systane® ULTRA lubricant eyedrops | Other |
|
| OPTIVE® lubricating eyedrops | Other |
|
| Day 35 |
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. | Day 35 |
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. | Day 35 |
| Withdrawal by subject prior to treatment |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mean Total Ocular Surface Staining (TOSS) Score | The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis. Here, the analysis group includes all randomized subjects with data at visit (46,47 respectively, for a total of 93). | Mean | Standard Deviation | units on a scale |
|
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). |
|
|
| Secondary | Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis. | This analysis group includes all subjects with data at visit. | Posted | Mean | Standard Deviation | units on a scale | Day 35 |
|
|
|
| Secondary | Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. | This analysis group includes all subjects with data at visit. | Posted | Mean | Standard Deviation | units on a scale | Day 35 |
|
|
|
| Secondary | Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. | This analysis group includes all subjects with data at visit. | Posted | Mean | Standard Deviation | units on a scale | Day 35 |
|
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| 1 |
| 105 |
| 1 |
| 105 |
| EG001 | Systane Ultra | All subjects who were exposed to Systane Ultra or run-in therapy | 1 | 46 | 2 | 46 |
| EG002 | Optive | All subjects who were exposed to Optive or run-in therapy | 0 | 47 | 3 | 47 |
| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.