An interventional study of SYSTANE® Lid Wipes and SYSTANE® BALANCE in Dry Eye Syndrome, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-29.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study was to assess the efficacy of the SYSTANE® family of products (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on meibomian gland functionality in subjects with lipid deficiency related to evaporative dry eye as compared to the standard of care warm compresses.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
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Exclusion Criteria:
SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
Other: SYSTANE® Lid Wipes · Other: SYSTANE® BALANCE · Dietary Supplement: SYSTANE® Vitamins
Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
Other: Microfiber towels (as warm compresses, with or without saline eye drops)
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
Lubricant Eye Drops
Also known as: SYSTANE® Vitamin Omega-3 Supplement
Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.
Time frame: Baseline, Month 1, Month 2, Month 3
Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
Time frame: Baseline, Month 1, Month 2, Month 3
Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses
The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire \[resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)\] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
Time frame: Baseline, Month 1, Month 2, Month 3
Participants were recruited from 1 study center located in the US.
| Milestone | SYSTANE® Family | Standard of Care |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.
| functioning glands | SYSTANE® Family | Standard of Care |
|---|---|---|
| Baseline | 3.5 ± 1.50 | 4.2 ± 1.39 |
| Month 1 | 7.0 ± 3.12 | 3.9 ± 1.76 |
| Month 2 | 6.4 ± 2.45 | 3.5 ± 1.90 |
| Month 3 | 9.3 ± 2.72 | 4.7 ± 2.29 |
The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
| units on a scale | SYSTANE® Family | Standard of Care |
|---|---|---|
| Baseline | 11.2 ± 2.59 | 11.2 ± 1.99 |
| Month 1 | 8.2 ± 3.24 | 9.5 ± 3.91 |
| Month 2 | 6.5 ± 3.02 | 7.9 ± 4.25 |
| Month 3 | 5.0 ± 3.42 | 7.9 ± 4.46 |
The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire \[resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)\] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
| units on a scale | SYSTANE® Family | Standard of Care |
|---|---|---|
| Baseline | 32.3 ± 12.82 | 26.9 ± 15.42 |
| Month 1 | 22.6 ± 10.48 | 21.0 ± 16.26 |
| Month 2 | 16.1 ± 9.57 | 19.7 ± 17.42 |
| Month 3 | 14.4 ± 10.20 | 17.9 ± 18.55 |
Collected over Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SYSTANE® Family | — | 0/13 (0%) | 1/13 (7.7%) |
| Standard of Care | — | 0/13 (0%) | 0/13 (0%) |
| Event | SYSTANE® Family | Standard of Care |
|---|---|---|
| Infectious mononucleosisInfections and infestations | 1/13 | 0/13 |
| SinusitisInfections and infestations | 1/13 | 0/13 |
This reporting group includes all subjects who were enrolled and received at least one of the study treatments.
| Age, Continuous(years) | SYSTANE® Family | Standard of Care | Total |
|---|---|---|---|
| Mean | 38.1 ± 19.9 | 45.4 ± 19.8 | 41.7 ± 19.8 |
| Sex: Female, Male(Participants) | SYSTANE® Family | Standard of Care | Total |
|---|---|---|---|
| Female | 11 | 10 | 21 |
| Male | 2 | 3 | 5 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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