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

Phase 3

Completed

• Conditions: Xerophthalmia; Blepharitis
• Interventions: Drug: Systane Ultra eyedrops; Drug: Refresh eye drops

• Registration Number: NCT00796926
• Lead Sponsor: Louis Tong

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

Study Timeline

• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2009-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2011-06-20
• Results First Submitted QC: 2011-07-19
• Results First Posted: 2011-08-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systane Ultra	Systane Ultra eyedrops	Used four times a day topically to each eye
Refresh	Refresh eye drops	Used four times a day topically to each eye

Primary Outcome Measures

Name	Time	Method
Visual Analog Score (VAS)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Singapore National Eye Center; 🇸🇬 Singapore, Singapore