The Effect of Systane Balance on Tear Film Break Up Time in Dry Eye Subjects
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01718028
First received: October 29, 2012
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to evaluate the ability of Systane Balance dosed four times a day for 30 days to increase non-invasive tear film break up time over baseline compared to a saline control in dry eye subjects with lipid deficiency.
| Condition | Intervention |
|---|---|
|
Dry Eye |
Other: Systane BALANCE eye drops Other: Saline eye drops |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Systane Balance on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean Change from Baseline in Non-Invasive Tear Film Break Up Time (NITFBUT) at 30 Days [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: No ]The subject will be instructed to blink naturally. After 10 seconds, the subject will stare straight ahead without blinking until told otherwise. The precorneal tear film will be viewed noninvasively using a Tearscope device, and the investigator will time the occurrence of the first break in the tear film, i.e., appearance of a dry area.
| Enrollment: | 51 |
| Study Start Date: | September 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Systane BALANCE
Systane BALANCE eye drops, one drop in each eye 4 times a day for 30 days
|
Other: Systane BALANCE eye drops
Systane BALANCE ocular emulsion, one drop in each eye 4 times daily for 30 days
Other Name: SYSTANE® BALANCE
|
|
Active Comparator: Saline
Saline eye drops, one drop in each eye 4 times a day for 30 days
|
Other: Saline eye drops
Sodium chloride 0.9% saline solution, one drop in each eye 4 times daily for 30 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Read, sign, and date an information consent letter;
- Willing and able to follow instructions and maintain the appointment schedule;
- Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
- Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
- Meet protocol-specified criteria for dry eye at Visit 1;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
- Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
- History of intolerance or hypersensitivity to any component of the study medications;
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
- Use of any concomitant topical ocular medications during the study period;
- Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
- Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
- Participation in an investigational drug or device study within 30 days of entering this study;
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01718028 History of Changes |
| Other Study ID Numbers: | RDG-11-262 |
| Study First Received: | October 29, 2012 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Argentina: CCIS - Comisión Conjunta de Investigación en Salud - Ministerio de Salud- La Provincia Buenos Aires Argentina: Human Research Bioethics Committee |
Keywords provided by Alcon Research:
|
Systane BALANCE Dry eye lipid deficiency NITFBUT |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Tetrahydrozoline |
Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013