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

NCT ID: NCT02446015

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-19
• Study Completion Date: 2016-06-21

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.

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.

Conditions

Dry Eye Syndrome

Study Design

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

Study Groups

Systane Ultra QID

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

Group Type: EXPERIMENTAL

SYSTANE® ULTRA Lubricant Eye Drops

Intervention Type: DRUG

Systane Ultra PRN

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

Group Type: ACTIVE_COMPARATOR

SYSTANE® ULTRA Lubricant Eye Drops

Intervention Type: DRUG

Interventions

SYSTANE® ULTRA Lubricant Eye Drops

Intervention Type: DRUG

Other Intervention Names

SYSTANE® ULTRA

Eligibility 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.

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.

• 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

Sr. Clinical Manager, GCRA

Role: STUDY_DIRECTOR

Alcon Research

References

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.

Reference Type: DERIVED

PMID: 29715369 (View on PubMed)

Other Identifiers

EXC120-P001

Identifier Type: -

Identifier Source: org_study_id