NL-OMON38494
Completed
Phase 4
Evaluation of Clinical Outcomes Following Treatment with Systane® Balance in Dry Eye Subjects with Lipid Deficiency - Clinical Outcomes Following Treatment with Systane Balance of Dry Eye
Alcon Laboratories0 sites48 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Alcon Laboratories
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willing and able to attend all study visits
- •2\. Must have all of the following in at least 1 eye at Screening (Day \-15\):
- •a. Meibomian Gland Dysfunction (MGD) grading for Expressibility \* 2 and Meibum Quality \* 2,
- •b. The average of 3 measures of TFBUT \< 5 seconds, and
- •c. Unanesthetized Schirmer I test of \* 3 mm
- •3\. Must have an Ocular Surface Disease Index (OSDI) Score \* 18 at Visit 1 (Day 0\) prior to randomization (ie, after 2 weeks of run\-in with Preservative\-Free 0\.9% Saline administered 4 times a day)
- •4\. Must have best\-corrected visual acuity of 55 letters or better in each eye as assessed using an ETDRS chart (letter read method)
- •5\. Physician diagnosis of dry eye at least 6 months prior to Screening visit
- •6\. Must be at least 18 years old and able to provide written informed consent
Exclusion Criteria
- •1\. Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening
- •2\. Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening. Note: Subjects who have been on a consistent lid hygiene regimen (ie, no change to the type of lid hygiene therapy that is being used as well as the frequency of use) for at least 30 days prior to Screening are not excluded. However, they cannot stop or change this regimen for the
- •duration of the study. In addition, subjects who do not currently use lid hygiene therapy cannot start for the duration of the study.
- •3\. Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening
- •4\. Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years) are excluded from participating in this study if they meet any of the following conditions:
- •\* They are currently pregnant, or
- •\* Test positive for pregnancy at Screening visit, or
- •\* They are currently breast feeding, or
- •\* Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
- •5\. Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products
Outcomes
Primary Outcomes
Not specified
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