An interventional study of Preservative-free saline solution eyedrops and Systane® ULTRA lubricant eyedrops in Dry Eye Syndrome, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-04.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 105 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
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Exclusion Criteria:
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).
Other: Preservative-free saline solution eyedrops · Other: Systane® ULTRA lubricant eyedrops
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).
Other: Preservative-free saline solution eyedrops · Other: OPTIVE® lubricating eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
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.
Time frame: Baseline, Day 35
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 35
Subjects were recruited from 13 study centers located in France and 3 study centers located in Germany.
| Milestone | Systane Ultra | Optive |
|---|---|---|
| Started | 46 | 48 |
| Treated | 46 | 47 |
| Completed | 43 | 41 |
| Not completed | 3 | 7 |
| Withdrew: Adverse event | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject prior to treatment | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | Systane Ultra | Optive |
|---|---|---|
| Started | 43 | 41 |
| Completed | 41 | 41 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| units on a scale | Systane Ultra | Optive |
|---|---|---|
| Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | -2.2 ± 2.3 | -1.7 ± 2.4 |
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.
| units on a scale | Systane Ultra | Optive |
|---|---|---|
| Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | 31.0 ± 18.3 | 35.4 ± 17.1 |
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.
| units on a scale | Systane Ultra | Optive |
|---|---|---|
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | 62.2 ± 27.3 | 55.7 ± 29.4 |
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.
| units on a scale | Systane Ultra | Optive |
|---|---|---|
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | 69.5 ± 15.8 | 67.1 ± 23.6 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-treatment | — | 1/105 (1%) | 1/105 (1%) |
| Systane Ultra | — | 1/46 (2.2%) | 2/46 (4.3%) |
| Optive | — | 0/47 (0%) | 3/47 (6.4%) |
| Event | Pre-treatment | Systane Ultra | Optive |
|---|---|---|---|
| Spinal column injuryInjury, poisoning and procedural complications | 0/105 | 1/46 | 0/47 |
| GastritisGastrointestinal disorders | 1/105 | 0/46 | 0/47 |
| Event | Pre-treatment | Systane Ultra | Optive |
|---|---|---|---|
| Eye irritationEye disorders | 1/105 | 2/46 | 3/47 |
This analysis group includes all randomized subjects.
| Age, Continuous(years) | Systane Ultra | Optive | Total |
|---|---|---|---|
| Mean | 63.5 ± 13.1 | 65.2 ± 14.3 | 64.4 ± 13.7 |
| Sex: Female, Male(Participants) | Systane Ultra | Optive | Total |
|---|---|---|---|
| Female | 39 | 40 | 79 |
| Male | 7 | 8 | 15 |
| Mean Total Ocular Surface Staining (TOSS) Score(units on a scale) | Systane Ultra | Optive | Total |
|---|---|---|---|
| Mean | 5.5 ± 1.9 | 5.5 ± 1.7 | 5.5 ± 1.8 |
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