- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01688726
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
May 31, 2018 updated by: Alcon Research
Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SYSTANE BALANCE
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
|
|
Active Comparator: Minims Saline
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Bulbar Conjunctival Staining
Time Frame: 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.
|
Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
Time Frame: 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.
|
Month 1
|
Non Invasive Tear Film Break-up-time (NIBUT)
Time Frame: 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.
|
Month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI, OTG Research & Consultancy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
September 17, 2012
First Submitted That Met QC Criteria
September 17, 2012
First Posted (Estimate)
September 20, 2012
Study Record Updates
Last Update Posted (Actual)
June 29, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A00977
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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