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

Louis Tong

Status and phase: Completed; Phase 3

Conditions: Blepharitis; Xerophthalmia

Treatments: Drug: Refresh eye drops; Drug: Systane Ultra eyedrops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00796926

R632/53/2008

Details and patient eligibility

About

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

Full description

Comparison of efficacy of Systane Ultra and Refresh Tears

Enrollment: 30 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Systane Ultra

Experimental group

Description:

Used four times a day topically to each eye

Treatment:

Drug: Systane Ultra eyedrops

Refresh

Active Comparator group

Description:

Used four times a day topically to each eye

Treatment:

Drug: Refresh eye drops