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

October 4, 2011 updated by: Louis Tong

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

Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of efficacy of Systane Ultra and Refresh Tears

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • Singapore National Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systane Ultra
Used four times a day topically to each eye
Drug: Systane Ultra eyedrops
Four times a day
Other Names:
  • Systane Ultra, Alcon
Active Comparator: Refresh
Used four times a day topically to each eye
Drug: Refresh eye drops
Four times a day
Other Names:
  • Refresh, Allergan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score (VAS)
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Fluorescein Staining Score
Time Frame: 6 weeks
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
6 weeks
Tear Break Up Time (TBUT)
Time Frame: 6 weeks
6 weeks
Schirmer I Reading
Time Frame: 6 weeks
6 weeks
Meibography Grading
Time Frame: 6 weeks
6 weeks
Tear Osmolarity
Time Frame: 6 weeks
This is measured by the TearLab (Ocusense) system
6 weeks
Superior and Inferior Tear Meniscus Height
Time Frame: 6 weeks
This is determined by anterior segment OCT visante system
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Tong

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Louis Tong, FRCS, MD, Singapore National Eye Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R632/53/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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