NCT01863368

Brief Summary

The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 10, 2015

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

May 23, 2013

Results QC Date

June 17, 2015

Last Update Submit

July 9, 2015

Conditions

Dry Eye Syndrome

Keywords

Dry eye syndromeSystane UltraOptiveOcular Surface StainingOSDIEye drops

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)

    The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.

    Baseline, Day 35

Secondary Outcomes (3)

  • Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)

    Day 35

  • Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)

    Day 35

  • Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)

    Day 35

Study Arms (2)

Systane Ultra

EXPERIMENTAL

Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).

Other: Preservative-free saline solution eyedropsOther: Systane® ULTRA lubricant eyedrops

Optive

ACTIVE COMPARATOR

OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).

Other: Preservative-free saline solution eyedropsOther: OPTIVE® lubricating eyedrops

Interventions

Preservative-free saline solution eyedropsOTHER

1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

OptiveSystane Ultra
Systane® ULTRA lubricant eyedropsOTHER
Systane Ultra
OPTIVE® lubricating eyedropsOTHER
Optive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to attend all study visits.
  • Diagnosis of dry eye, as specified in protocol.
  • Uses artificial tears, as specified in protocol.

You may not qualify if:

  • Poor visual acuity, as specified in protocol.
  • Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
  • Any hypersensitivity or allergy to the investigational products or ingredients.
  • Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
  • Contact lens use within 2 weeks of Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15.

    PMID: 27422973DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Global Brand Med Affairs Lead, Pharma, GCRA
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Steve Burmaster

    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
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 27, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 4, 2015

Results First Posted

July 10, 2015

Record last verified: 2015-07