Overview

This trial is active, not recruiting.

Condition dry eye
Treatments propylene glycol, 0.6% eye drops, preservative-free 0.9% saline solution
Sponsor Alcon Research
Start date February 2014
End date January 2015
Trial size 294 participants
Trial identifier NCT01967147, M-13-027

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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).
propylene glycol, 0.6% eye drops Systane® Balance
Commercially available eye drops used during Treatment Phase
(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).
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

Primary Outcomes

Measure
Change from baseline in tear film break-up time (TFBUT) at Day 35
time frame: Baseline (Day 0), Day 35

Secondary Outcomes

Measure
Change from baseline in Total Ocular Surface Staining (TOSS) score at Day 35
time frame: Baseline (Day 0), Day 35
Change from baseline in ocular surface disease index (OSDI) score at Day 35
time frame: Baseline (Day 0), Day 35
Change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness score at Day 35
time frame: Baseline (Day 0), Day 35
Change from baseline in IDEEL Treatment Inconvenience score at Day 35
time frame: Baseline (Day 0), Day 35

Eligibility Criteria

Male or female participants at least 18 years old.

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 meet 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.

Additional Information

Official title Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency
Description A 15-day Run-in phase will precede a 90-day Treatment period. The Treatment period will be conducted in 2 phases. In Phase 1, participants will be randomized to either Systane® Balance or Saline and dose 4 times a day for 35 days. In Phase II (Day 35-90) participants will continue to dose with their assigned product on an as-needed basis.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Alcon Research.