N/A N=54 Randomized Double-blind Treatment

SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

Dry Eye Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01733732 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Nov 2014

Primary outcome: Primary: Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit — -7.85; -12.58; -10.23; -16.74 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SYSTANE® BALANCE Lubricant Eye Drops (Other); SYSTANE® Gel (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit	-7.85; -12.58; -10.23; -16.74	—
SECONDARY Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit	-0.02; -0.01; -0.02; -0.02	—
SECONDARY Percentage of Eyes With Normal Slit-lamp Assessment	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Meibomian Gland Expression	1.4; 1.6; 1.2; 1.3; 1.2; 1.3	—
SECONDARY Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit	0.587; -0.325; -0.914; 1.261	—
SECONDARY Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit	0.146; 0.089; 0.140; 0.165	—
SECONDARY Mean Change From Baseline in Ocular Surface Staining by Visit	-1.0; -0.9; -1.3; -1.6; -0.7; -0.7	—
SECONDARY Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30	2.680; 15.146; 0.192; 0.335; 0.902; 0.735	—
SECONDARY Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30	-0.751; -0.300	—
SECONDARY Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30	0.079; 0.019; -0.061; 0.009	—
SECONDARY Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit	-0.3; 2.8; 4.6; 2.6	—
SECONDARY Mean Change From Baseline in Intraocular Pressure (IOP) by Visit	0.0; 0.2; 0.1; -0.1	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01733732). 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.