Clinical trial NCT01733732: SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
Official title: Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry eye
Lipid deficiency
Inflammatory markers
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.


Eligibility criteria: Inclusion Criteria:

* Read, sign, and date the Informed Consent Document;
* Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
* Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
* Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
* 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;
* Use of any concomitant topical ocular medications during the study period;
* Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire 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 and that remains stable throughout the study;
* Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
Secondary outcomes:
measure: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Percentage of Eyes With Normal Slit-lamp Assessment
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Meibomian Gland Expression
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Mean Change From Baseline in Ocular Surface Staining by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30
timeFrame: Baseline (Day 0), Day 30
measure: Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30
timeFrame: Baseline (Day 0), Day 30
measure: Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30
timeFrame: Baseline (Day 0), Day 30
measure: Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Mean Change From Baseline in Intraocular Pressure (IOP) by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Abayomi Ogundele, PharmD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Penny A. Asbell, MD
role: PRINCIPAL_INVESTIGATOR
References: