Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

NCT ID: NCT01967147

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-01-31

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Systane Balance

Propylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).

Group Type: EXPERIMENTAL

Propylene Glycol, 0.6% eye drops

Intervention Type: DRUG

Commercially available eye drops used during Treatment Phase

Saline

Preservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).

Group Type: ACTIVE_COMPARATOR

Preservative-free 0.9% Saline solution

Intervention Type: DRUG

Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase

Interventions

Propylene Glycol, 0.6% eye drops

Commercially available eye drops used during Treatment Phase

Intervention Type: DRUG

Preservative-free 0.9% Saline solution

Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase

Intervention Type: DRUG

Other Intervention Names

Systane® Balance

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Clinical Manager, GCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-13-027

Identifier Type: -

Identifier Source: org_study_id