N/A
N=26
SYSTANE® Family - Meibomian Deficiency
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01733745 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) — 3.5; 4.2; 7.0; 3.9 functioning glands
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SYSTANE® Lid Wipes (Other); SYSTANE® BALANCE (Other); SYSTANE® Vitamins (Dietary_supplement); Microfiber towels (as warm compresses, with or without saline eye drops) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Meibomian Glands Yielding Liquid Secretion (MGLYS) |
3.5; 4.2; 7.0; 3.9; 6.4; 3.5 | — |
| SECONDARY Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses |
11.2; 11.2; 8.2; 9.5; 6.5; 7.9 | — |
| SECONDARY Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses |
32.3; 26.9; 22.6; 21.0; 16.1; 19.7 | — |
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.
Eligibility Criteria
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 exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01733745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.