Systane Family - Meibomian Deficiency
This study is currently recruiting participants.
Verified March 2013 by Alcon Research
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01733745
First received: November 21, 2012
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
The purpose of this study is 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.
| Condition | Intervention |
|---|---|
|
Dry Eye Syndrome |
Other: Systane Lid Wipes Other: SYSTANE BALANCE Lubricant Eye Drops Dietary Supplement: Systane Vitamins Other: Microfiber towels |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Systane Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Meibomian Glands Yielding Liquid Secretion (MGLYS) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]Meibomian gland functionality will be 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 number of meibomian gland orificies evidencing liquid secretion during expression with the MGE will be documented.
Secondary Outcome Measures:
- Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses [ Time Frame: Month 3 ] [ Designated as safety issue: No ]The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire will be completed by the patient with no assistance from the office staff, physician, or anyone else.
- Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses [ Time Frame: Month 3 ] [ Designated as safety issue: No ]The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire (resultant overall 0-100 score) that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire will be completed by the patient with no assistance from the office staff, physician, or anyone else.
| Estimated Enrollment: | 26 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Systane Family
Systane Lid Wipes administered to treated eye(s) twice a day; Systane Balance lubricant eye drops administered to treated eye(s), one drop four times a day; Systane Vitamins, two softgels ingested daily. Duration of treatment is 3 months.
|
Other: Systane Lid Wipes
Systane Lid Wipes pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
Other Name: SYSTANE™ LID WIPES
Other: SYSTANE BALANCE Lubricant Eye Drops
Other Name: SYSTANE® BALANCE
Dietary Supplement: Systane Vitamins
Other Name: SYSTANE™ Vitamin Omega-3 Supplement
|
|
Active Comparator: Standard of Care
Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, one time a day. Duration of treatment is 3 months.
|
Other: Microfiber towels |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 6/60 (20/20 Snellen, 1.0 logMAR) 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 six 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 one 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733745
Contacts
| Contact: Alcon Call Center | 1-888-451-3937 |
Locations
| United States, Texas | |
| Contact Alcon Call Center for Trial Locations | Recruiting |
| Fort Worth, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
Investigators
| Study Director: | Beth Scott, O.D., MS, FAAO | Alcon Research |
| Principal Investigator: | Donald R Korb, O.D. | Korb and Associates |
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01733745 History of Changes |
| Other Study ID Numbers: | A00978 |
| Study First Received: | November 21, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
dry eye lipid deficiency meibomian gland |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Tetrahydrozoline Vitamins Nasal Decongestants |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013