MedDataX Logo

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

NCT ID: NCT00796926

Last Updated: 2011-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Comparison of efficacy of Systane Ultra and Refresh Tears

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Xerophthalmia Blepharitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Systane Ultra

Used four times a day topically to each eye

Group Type EXPERIMENTAL

Systane Ultra eyedrops

Intervention Type DRUG

Four times a day

Refresh

Used four times a day topically to each eye

Group Type ACTIVE_COMPARATOR

Refresh eye drops

Intervention Type DRUG

Four times a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Systane Ultra eyedrops

Four times a day

Intervention Type DRUG

Refresh eye drops

Four times a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Systane Ultra, Alcon Refresh, Allergan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role collaborator

Louis Tong

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Louis Tong

Clinician-Scientist, Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louis Tong, FRCS, MD

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Singapore National Eye Center

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R632/53/2008

Identifier Type: -

Identifier Source: org_study_id