Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency - Full Text View

Purpose

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.

Condition	Intervention
Dry Eye Syndrome Lipid Deficiency	Other: SYSTANE® BALANCE eyedrops Other: Minims® Saline 0.9% eyedrops


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Tears

Drug Information available for: Propylene glycol Tetrahydrozoline hydrochloride Boric acid

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean Bulbar Conjunctival Staining [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
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:

High Contrast logMAR Time Controlled Visual Acuity (TCVA) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
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.
Non Invasive Tear Film Break-up-time (NIBUT) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
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.


Enrollment:	91
Study Start Date:	December 2012
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SYSTANE BALANCE SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month	Other: SYSTANE® BALANCE eyedrops
Active Comparator: Minims Saline Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month	Other: Minims® Saline 0.9% eyedrops

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688726

Sponsors and Collaborators

Alcon Research

Investigators


Principal Investigator:	Michel Guillon, PhD, FCOptom, FAAO, CCTI	OTG Research & Consultancy

More Information

No publications provided


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01688726 History of Changes
Other Study ID Numbers:	A00977
Study First Received:	September 17, 2012
Results First Received:	November 11, 2014
Last Updated:	November 18, 2014
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:


Dry eye Ocular surface Vision complaint	Tear film stability Time controlled functional visual acuity Tear film kinetics

Additional relevant MeSH terms:


Ophthalmic Solutions Tetrahydrozoline Autonomic Agents Cardiovascular Agents Nasal Decongestants Peripheral Nervous System Agents Pharmaceutical Solutions	Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sympathomimetics Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 03, 2015