Clinical trial NCT01967147: Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects
Official title: Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
Lipid deficiency
Tear film break-up time
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-10-22
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.

Detailed description: This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.

Eligibility criteria: Inclusion Criteria:

* Must have all of the following in at least 1 eye at Screening:

  1. Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2,
  2. The average of 3 measures of TFBUT ≤ 5 seconds, and
  3. Unanesthetized Schirmer I test of ≥ 3 mm.
* Must have an Ocular Surface Disease Index (OSDI) Score ≥ 18 at Visit 1 prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day).
* Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart (letter read method).
* Physician diagnosis of dry eye at least 6 months prior to Screening visit.
* Willing and able to attend all study visits.
* Must sign a written informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening.
* Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening.
* Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening.
* Women of childbearing potential are excluded from participating in this study if they met any of the following conditions:

  * Currently pregnant, or
  * Test positive for pregnancy at Screening visit, or
  * Currently breast feeding, or
  * Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products.
* Has an active ocular allergy.
* Any ocular abnormalities that could adversely affect the safety or efficacy outcome, including eyelid anomalies, corneal disorders, history of herpes simplex, etc.
* Subjects taking any systemic medication known to cause dry eye unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study.
* History of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants, or serious ocular trauma within 1 year of Screening.
* Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc.
* Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening.
* Any significant illnesses that could be expected to interfere with the study parameters.
* Subjects with active oculodermal rosacea with meibomian gland dysfunction.
* Participation in an investigational drug or device trial within 30 days of Screening.
* Contact lens use within 30 days prior to Screening, or unwilling to avoid contact lens use during the course of the study.
* Unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in TFBUT at Day 35
timeFrame: Baseline (Day 0), Day 35
Secondary outcomes:
measure: Change From Baseline in TOSS Score at Day 35
timeFrame: Baseline (Day 0), Day 35
measure: Change From Baseline in OSDI Score at Day 35
timeFrame: Baseline (Day 0), Day 35
measure: Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35
timeFrame: Baseline (Day 0), Day 35
measure: Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35
timeFrame: Baseline (Day 0), Day 35
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Senior Clinical Manager, GCRA
role: STUDY_DIRECTOR
References: