NCT00796926

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 12, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

1.3 years

First QC Date

November 21, 2008

Results QC Date

June 20, 2011

Last Update Submit

October 4, 2011

Conditions

XerophthalmiaBlepharitis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks

Secondary Outcomes (6)

  • Corneal Fluorescein Staining Score

    6 weeks

  • Tear Break Up Time (TBUT)

    6 weeks

  • Schirmer I Reading

    6 weeks

  • Meibography Grading

    6 weeks

  • Tear Osmolarity

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Systane Ultra

EXPERIMENTAL

Used four times a day topically to each eye

Drug: Systane Ultra eyedrops

Refresh

ACTIVE COMPARATOR

Used four times a day topically to each eye

Drug: Refresh eye drops

Interventions

Systane Ultra eyedropsDRUG

Four times a day

Also known as: Systane Ultra, Alcon
Systane Ultra
Refresh eye dropsDRUG

Four times a day

Also known as: Refresh, Allergan
Refresh

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Center

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

XerophthalmiaBlepharitis

Interventions

methylacetylene

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEyelid Diseases

Results Point of Contact

Title
Dr Louis Tong
Organization
Singapore National Eye Center
Louis.tong.h.t@snec.com.sg
65 62277255

Study Officials

  • Louis Tong, FRCS, MD

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinician-Scientist, Consultant

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

October 7, 2011

Results First Posted

August 12, 2011

Record last verified: 2011-10

Locations

SG(1)