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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome; Lipid Deficiency
• Interventions: Other: SYSTANE® BALANCE eyedrops; Other: Minims® Saline 0.9% eyedrops

• Registration Number: NCT01688726
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Study Start: 2012-12
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-08
• Results First Submitted: 2014-11-11
• Results First Submitted QC: 2014-11-11
• Results First Posted: 2014-11-18
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYSTANE BALANCE	SYSTANE® BALANCE eyedrops	SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Minims Saline	Minims® Saline 0.9% eyedrops	Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month

Primary Outcome Measures

Name	Time	Method
Mean Bulbar Conjunctival Staining	Month 1	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.

Secondary Outcome Measures

Name	Time	Method
Non Invasive Tear Film Break-up-time (NIBUT)	Month 1	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.
High Contrast logMAR Time Controlled Visual Acuity (TCVA)	Month 1	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.