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

NCT02446015 | Completed Results

• 1 other identifier: EXC120-P001
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Ocular Surface Staining (TOSS) Score at 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.

  Baseline (Day 0), Day 28

Secondary Outcomes (2)

• Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28

  Baseline (Day 0), Day 28

• Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28

  Baseline (Day 0), Day 28

Study Arms (2)

Systane Ultra QID

EXPERIMENTAL

SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days

Drug: SYSTANE® ULTRA Lubricant Eye Drops

Systane Ultra PRN

ACTIVE COMPARATOR

SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days

Drug: SYSTANE® ULTRA Lubricant Eye Drops

Interventions

SYSTANE® ULTRA Lubricant Eye Drops DRUG

Also known as: SYSTANE® ULTRA

Systane Ultra PRN; Systane Ultra QID

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• 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.

  PMID: 29715369 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: WW Medical Affairs Director, GMA Ophthalmics
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. 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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Study Start: June 19, 2015
• Primary Completion: June 21, 2016
• Study Completion: June 21, 2016
• Last Updated: July 2, 2018
• Results First Posted: June 16, 2017

Record last verified: 2017-04