Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

Dry Eye Syndrome Clinical Trial

Official title:

Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688726
• Other study ID #: A00977
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-contact lens wearer;

• Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;

• Lipid deficiency;

• Best visual acuity of 6/9 or better in each eye;

• Willingness to adhere to the instructions set in the clinical protocol;

• Signature of the subject informed consent form;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Use of systemic medication which might produce dry eye side effects;

• Systemic disease which might produce dry eye side effects;

• Active or recent ocular inflammation or infection;

• Use of ocular medication;

• Significant ocular anomaly;

• Previous ocular surgery;

• Previous use of Restasis;

• Any medical condition that might be prejudicial to the study;

• Pregnant or lactating;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Lipid Deficiency

Intervention

Other:
• SYSTANE® BALANCE eyedrops

• Minims® Saline 0.9% eyedrops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Bulbar Conjunctival Staining	The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.	Month 1
Secondary	High Contrast logMAR Time Controlled Visual Acuity (TCVA)	TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.	Month 1
Secondary	Non Invasive Tear Film Break-up-time (NIBUT)	NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.	Month 1

External Links

•   Results from the Novartis Clinical Trial Results Website