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

Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796926
• Other study ID #: R632/53/2008
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2008
• Last updated: October 4, 2011
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2011
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

Description:

Comparison of efficacy of Systane Ultra and Refresh Tears

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis
• Xerophthalmia

Intervention

Drug:
• Systane Ultra eyedrops
Four times a day
• Refresh eye drops
Four times a day

Locations

Country	Name	City	State
Singapore	Singapore National Eye Center	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Louis Tong	Alcon Research

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	6 weeks	Yes
Secondary	Tear Break Up Time (TBUT)		6 weeks	Yes
Secondary	Schirmer I Reading		6 weeks	Yes
Secondary	Meibography Grading		6 weeks	Yes
Secondary	Tear Osmolarity	This is measured by the TearLab (Ocusense) system	6 weeks	Yes
Secondary	Superior and Inferior Tear Meniscus Height	This is determined by anterior segment OCT visante system	6 weeks	Yes