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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE® Family | Experimental | 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. |
|
| Standard of Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTANE® Lid Wipes | Other | Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 1, Month 2, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danyel C. Carr, MS, CCRA | Alcon Research | Study Director |
| Donald R Korb, O.D. | Korb and Associates | Principal Investigator |
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This reporting group includes all subjects who were enrolled and received at least one of the study treatments (26).
Participants were recruited from 1 study center located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | SYSTANE® Family | 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. |
| FG001 | Standard of Care | Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This reporting group includes all subjects who were enrolled and received at least one of the study treatments.
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| ID | Title | Description |
|---|---|---|
| BG000 | SYSTANE® Family | 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. |
| BG001 | Standard of Care |
| 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 | 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. | This reporting group includes all subjects who were enrolled and received at least one of the study treatments. | Posted | Mean | Standard Deviation | functioning glands | Baseline, Month 1, Month 2, Month 3 | Eyes | Eyes |
|
Adverse events (AEs) were collected for the duration of the study (4 months). This analysis group includes all enrolled and exposed subjects.
An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments by the participant.
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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® Family | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious mononucleosis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abayomi Ogundele, Pharm.D, 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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| SYSTANE® BALANCE | Other | Lubricant Eye Drops |
|
| SYSTANE® Vitamins | Dietary Supplement |
|
|
| Microfiber towels (as warm compresses, with or without saline eye drops) | Other |
|
| 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. | Baseline, Month 1, Month 2, Month 3 |
Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Standard of Care | Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months. |
|
|
| Secondary | 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. | This reporting group includes all subjects who were enrolled and received at least one of the study treatments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, Month 2, Month 3 | Eyes | Eyes |
|
|
|
| Secondary | 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. | This reporting group includes all subjects who were enrolled and received at least one of the study treatments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, Month 2, Month 3 | Eyes | Eyes |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Standard of Care | Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months. | 0 | 13 | 0 | 13 |
| Sinusitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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