Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

• ClinicalTrials.gov Identifier: NCT02446015
• Recruitment Status: Completed
• First Posted: May 15, 2015
• Results First Posted: June 16, 2017
• Last Update Posted: July 2, 2018
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndrome	Drug: SYSTANE® ULTRA Lubricant Eye Drops	Not Applicable

Detailed Description:

This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
• Actual Study Start Date: June 19, 2015
• Actual Primary Completion Date: June 21, 2016
• Actual Study Completion Date: June 21, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Systane Ultra QID; SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days	Drug: SYSTANE® ULTRA Lubricant Eye Drops; Other Name: SYSTANE® ULTRA
Active Comparator: Systane Ultra PRN; SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days	Drug: SYSTANE® ULTRA Lubricant Eye Drops; Other Name: SYSTANE® ULTRA

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 [ Time Frame: Baseline (Day 0), Day 28 ]
   The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

Secondary Outcome Measures :

1. Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 [ Time Frame: Baseline (Day 0), Day 28 ]
   The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
2. Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 [ Time Frame: Baseline (Day 0), Day 28 ]
   The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Willing and able to attend all study visits.
• Use of BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day).
• At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear.
• Use provided artificial tear at least once a week during run-in phase.
• Willing to take study treatment as directed for the entire study and able to complete the study diaries as required.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Use of artificial tears, as specified in the protocol.
• Use of topical ocular medications, as specified in the protocol.
• Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
• Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations.
• Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol.
• Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit.
• Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study.
• Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study.
• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, GCRA; Alcon Research

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Asbell P, Vingrys AJ, Tan J, Ogundele A, Downie LE, Jerkins G, Shettle L. Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2275-2280. doi: 10.1167/iovs.17-23733.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02446015
• Other Study ID Numbers: EXC120-P001
• First Posted: May 15, 2015
• Results First Posted: June 16, 2017
• Last Update Posted: July 2, 2018
• Last Verified: April 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Ophthalmic Solutions; Lubricant Eye Drops; Pharmaceutical Solutions