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Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01688726
First received: September 17, 2012
Last updated: November 18, 2014
Last verified: November 2014
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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:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
- 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.
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01688726
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
| 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 |
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:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Ophthalmic Solutions |
Tetrahydrozoline Pharmaceutical Solutions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on July 27, 2017