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

• Sponsor: Louis Tong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00796926
• Collaborator: Alcon Research (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Xerophthalmia; Blepharitis	Drug: Systane Ultra eyedrops; Drug: Refresh eye drops	Phase 3

Detailed Description

Comparison of efficacy of Systane Ultra and Refresh Tears

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Tear Break Up Time (TBUT) [6 weeks]

3. Schirmer I Reading [6 weeks]

4. Meibography Grading [6 weeks]

5. Tear Osmolarity [6 weeks]

   This is measured by the TearLab (Ocusense) system

6. Superior and Inferior Tear Meniscus Height [6 weeks]

   This is determined by anterior segment OCT visante system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye

2. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice)

3. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks.

4. Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day).

5. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre
• ClinicalTrials.gov Identifier: NCT00796926
• Other Study ID Numbers: R632/53/2008
• First Posted: Nov 24, 2008
• Last Update Posted: Oct 7, 2011
• Last Verified: Oct 1, 2011

• Additional relevant MeSH terms: Blepharitis; Xerophthalmia; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Systane Ultra	Refresh
Arm/Group Description	four times a day for six weeks in each eye	Four times a day for 6 weeks in each eye
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	15
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Systane Ultra	Refresh	Total
Arm/Group Description	four times a day for six weeks in each eye	Four times a day for 6 weeks in each eye	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.2 (5.8)	55.7 (5.5)	55.9 (5.6)
Sex: Female, Male (Count of Participants)
Female	12 80%	14 93.3%	26 86.7%
Male	3 20%	1 6.7%	4 13.3%
Region of Enrollment (participants) [Number]
Singapore	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Score (VAS)
Description	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
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Systane Ultra	Refresh
Arm/Group Description	four times a day for six weeks in each eye	Four times a day for 6 weeks in each eye
Measure Participants	14	15
Mean (Standard Deviation) [scores on a scale]	21.55 (16.8)	27.27 (15.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Systane Ultra, Refresh
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Corneal Fluorescein Staining Score
Description	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
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Tear Break Up Time (TBUT)
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Schirmer I Reading
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Meibography Grading
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Tear Osmolarity
Description	This is measured by the TearLab (Ocusense) system
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Superior and Inferior Tear Meniscus Height
Description	This is determined by anterior segment OCT visante system
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Systane Ultra		Refresh
Arm/Group Description	four times a day for six weeks in each eye		Four times a day for 6 weeks in each eye
All Cause Mortality
	Systane Ultra		Refresh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Ultra		Refresh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Systane Ultra		Refresh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.