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Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes

Primary Purpose

Xerophthalmia, Blepharitis

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Systane Ultra eyedrops
Refresh eye drops
Sponsored by
Louis Tong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerophthalmia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject age is between 40 and 65 years old.
  2. Corneal fluorescein staining present in at least one/five sectors of at least one cornea

  3. At least one question out of 6 questions on dry eye symptom present often or all the time.

    based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.

  4. At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye
  5. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice)
  6. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks.
  7. Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day).
  8. Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days.

Exclusion Criteria:

  1. Known history of thyroid disorders (diagnosed by physician).
  2. Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).
  3. No ocular surgery within 6 months and LASIK within 1 year.
  4. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
  5. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
  6. Anticipated necessity to wear contact lens in the duration of the study.
  7. Not living in the same household as another participant of the study.
  8. Any other specified reason as determined by clinical investigator.

Sites / Locations

  • Singapore National Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Systane Ultra

Refresh

Arm Description

Used four times a day topically to each eye

Used four times a day topically to each eye

Outcomes

Primary Outcome Measures

Visual Analog Score (VAS)
Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum

Secondary Outcome Measures

Corneal Fluorescein Staining Score
This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any
Tear Break Up Time (TBUT)
Schirmer I Reading
Meibography Grading
Tear Osmolarity
This is measured by the TearLab (Ocusense) system
Superior and Inferior Tear Meniscus Height
This is determined by anterior segment OCT visante system

Full Information

First Posted
November 21, 2008
Last Updated
October 4, 2011
Sponsor
Louis Tong
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00796926
Brief Title
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Official Title
Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louis Tong
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes
Detailed Description
Comparison of efficacy of Systane Ultra and Refresh Tears

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerophthalmia, Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systane Ultra
Arm Type
Experimental
Arm Description
Used four times a day topically to each eye
Arm Title
Refresh
Arm Type
Active Comparator
Arm Description
Used four times a day topically to each eye
Intervention Type
Drug
Intervention Name(s)
Systane Ultra eyedrops
Other Intervention Name(s)
Systane Ultra, Alcon
Intervention Description
Four times a day
Intervention Type
Drug
Intervention Name(s)
Refresh eye drops
Other Intervention Name(s)
Refresh, Allergan
Intervention Description
Four times a day
Primary Outcome Measure Information:
Title
Visual Analog Score (VAS)
Description
Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Corneal Fluorescein Staining Score
Description
This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any
Time Frame
6 weeks
Title
Tear Break Up Time (TBUT)
Time Frame
6 weeks
Title
Schirmer I Reading
Time Frame
6 weeks
Title
Meibography Grading
Time Frame
6 weeks
Title
Tear Osmolarity
Description
This is measured by the TearLab (Ocusense) system
Time Frame
6 weeks
Title
Superior and Inferior Tear Meniscus Height
Description
This is determined by anterior segment OCT visante system
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject age is between 40 and 65 years old. Corneal fluorescein staining present in at least one/five sectors of at least one cornea At least one question out of 6 questions on dry eye symptom present often or all the time. based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1. At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice) Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks. Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day). Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days. Exclusion Criteria: Known history of thyroid disorders (diagnosed by physician). Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician). No ocular surgery within 6 months and LASIK within 1 year. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos. Anticipated necessity to wear contact lens in the duration of the study. Not living in the same household as another participant of the study. Any other specified reason as determined by clinical investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Tong, FRCS, MD
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Center
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

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Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes

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