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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00796926
First received: November 21, 2008
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Xerophthalmia
Blepharitis
 Drug: Systane Ultra eyedrops
Drug: Refresh eye drops
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Visual Analog Score (VAS) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Schirmer I Reading [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Meibography Grading [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Tear Osmolarity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    This is measured by the TearLab (Ocusense) system

  • Superior and Inferior Tear Meniscus Height [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    This is determined by anterior segment OCT visante system


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane Ultra
Used four times a day topically to each eye
 Drug: Systane Ultra eyedrops
Four times a day
Other Name: Systane Ultra, Alcon
Active Comparator: Refresh
Used four times a day topically to each eye
 Drug: Refresh eye drops
Four times a day
Other Name: Refresh, Allergan

Detailed Description:

Comparison of efficacy of Systane Ultra and Refresh Tears

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796926

Locations
Singapore
Singapore National Eye Center
Singapore, Singapore, 168751
Sponsors and Collaborators
Louis Tong
Alcon Research
Investigators
Principal Investigator: Louis Tong, FRCS, MD Singapore National Eye Centre
  More Information

No publications provided

Responsible Party: Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00796926     History of Changes
Other Study ID Numbers: R632/53/2008
Study First Received: November 21, 2008
Results First Received: June 20, 2011
Last Updated: October 4, 2011
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Blepharitis
Xerophthalmia
Eyelid Diseases
Eye Diseases
Conjunctival Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Tetrahydrozoline
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013