Dry Eye Syndrome
Conditions
Keywords
dry eye, lipid deficiency, meibomian gland
Brief summary
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.
Interventions
OTHERSYSTANE® Lid Wipes
Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
OTHERSYSTANE® BALANCE
Lubricant Eye Drops
DIETARY_SUPPLEMENTSYSTANE® Vitamins
OTHERMicrofiber towels (as warm compresses, with or without saline eye drops)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye; * Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion; * Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction management prior to receiving the study test article at Visit 1, up until the end of the study period; * Must have best corrected visual acuity of 20/40 Snellen or better in each eye; * Must be able to follow instructions and be willing and able to attend required study visits; * Must read, sign, and date an Ethics Committee reviewed and approved informed consent form; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months; * Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs); * History of intolerance or hypersensitivity to any component of the study medications; * History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye; * Pregnant or lactating at the time of enrollment; * Not willing to take adequate precautions not to become pregnant during the study; * Use of any concomitant topical ocular medications during the study period; * Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1; * Ocular conditions that may preclude the safe administration of either drop under investigation; * Unwilling to discontinue contact lens wear during the study period and for at least 1 week prior to Visit 1; * Participation in an investigational drug or device study within 30 days of entering this study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Baseline, Month 1, Month 2, Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Baseline, Month 1, Month 2, Month 3 | 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. |
| Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Baseline, Month 1, Month 2, Month 3 | 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. |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the US.
Pre-assignment details
This reporting group includes all subjects who were enrolled and received at least one of the study treatments (26).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | SYSTANE® Family | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 19.9 | 45.4 years STANDARD_DEVIATION 19.8 | 41.7 years STANDARD_DEVIATION 19.8 |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: Baseline, Month 1, Month 2, Month 3
Population: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE® Family | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Month 2 | 6.4 functioning glands | Standard Deviation 2.45 |
| SYSTANE® Family | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Baseline | 3.5 functioning glands | Standard Deviation 1.5 |
| SYSTANE® Family | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Month 3 | 9.3 functioning glands | Standard Deviation 2.72 |
| SYSTANE® Family | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Month 1 | 7.0 functioning glands | Standard Deviation 3.12 |
| Standard of Care | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Month 3 | 4.7 functioning glands | Standard Deviation 2.29 |
| Standard of Care | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Month 1 | 3.9 functioning glands | Standard Deviation 1.76 |
| Standard of Care | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Month 2 | 3.5 functioning glands | Standard Deviation 1.9 |
| Standard of Care | Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) | Baseline | 4.2 functioning glands | Standard Deviation 1.39 |
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.
Time frame: Baseline, Month 1, Month 2, Month 3
Population: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE® Family | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Baseline | 32.3 units on a scale | Standard Deviation 12.82 |
| SYSTANE® Family | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Month 1 | 22.6 units on a scale | Standard Deviation 10.48 |
| SYSTANE® Family | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Month 2 | 16.1 units on a scale | Standard Deviation 9.57 |
| SYSTANE® Family | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Month 3 | 14.4 units on a scale | Standard Deviation 10.2 |
| Standard of Care | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Month 3 | 17.9 units on a scale | Standard Deviation 18.55 |
| Standard of Care | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Baseline | 26.9 units on a scale | Standard Deviation 15.42 |
| Standard of Care | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Month 2 | 19.7 units on a scale | Standard Deviation 17.42 |
| Standard of Care | Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses | Month 1 | 21.0 units on a scale | Standard Deviation 16.26 |
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.
Time frame: Baseline, Month 1, Month 2, Month 3
Population: This reporting group includes all subjects who were enrolled and received at least one of the study treatments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE® Family | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Baseline | 11.2 units on a scale | Standard Deviation 2.59 |
| SYSTANE® Family | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Month 1 | 8.2 units on a scale | Standard Deviation 3.24 |
| SYSTANE® Family | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Month 2 | 6.5 units on a scale | Standard Deviation 3.02 |
| SYSTANE® Family | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Month 3 | 5.0 units on a scale | Standard Deviation 3.42 |
| Standard of Care | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Month 3 | 7.9 units on a scale | Standard Deviation 4.46 |
| Standard of Care | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Baseline | 11.2 units on a scale | Standard Deviation 1.99 |
| Standard of Care | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Month 2 | 7.9 units on a scale | Standard Deviation 4.25 |
| Standard of Care | Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses | Month 1 | 9.5 units on a scale | Standard Deviation 3.91 |