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

NCT01967147 | Completed Results

• 1 other identifier: M-13-027
• Study Type: interventional
• Target: 279
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye

Keywords

Dry eye; Lipid deficiency; Tear film break-up time

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in TFBUT at Day 35

  TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.

  Baseline (Day 0), Day 35

Secondary Outcomes (4)

• Change From Baseline in TOSS Score at Day 35

  Baseline (Day 0), Day 35

• Change From Baseline in OSDI Score at Day 35

  Baseline (Day 0), Day 35

• Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35

  Baseline (Day 0), Day 35

• Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35

  Baseline (Day 0), Day 35

Study Arms (2)

Systane Balance

EXPERIMENTAL

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).

Drug: Propylene Glycol, 0.6% eye drops

Saline

ACTIVE COMPARATOR

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).

Drug: Preservative-free 0.9% Saline solution

Interventions

Propylene Glycol, 0.6% eye drops DRUG

Commercially available eye drops used during Treatment Phase

Also known as: Systane® Balance

Systane Balance

Preservative-free 0.9% Saline solution DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have all of the following in at least 1 eye at Screening:
• Meibomian Gland Dysfunction (MGD) grading for Expressibility ≤ 2 and Meibum Quality ≤ 2,
• The average of 3 measures of TFBUT ≤ 5 seconds, and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene Glycol; Ophthalmic Solutions; Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Crystalloid Solutions; Isotonic Solutions

Results Point of Contact

• Title: Global Brand Med Affairs Lead, GCRA, GMA Pharma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Senior Clinical Manager, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 22, 2013
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 23, 2016
• Results First Posted: March 23, 2016

Record last verified: 2016-02