Dry EyePhase 3NCT01240382

Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

A Phase 3 study testing 3% DE-089 ophthalmic solution and 0.1% sodium hyaluronate ophthalmic solution in people with Dry Eye, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Dry Eye
What is being tested?: 3% DE-089 ophthalmic solution and 0.1% sodium hyaluronate ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 332 participants
Where: 1 siteJapan
Study dates: Start not givento Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Adult, Older adult

Who may be able to join

Those who show:
Keratoconjunctival disorder confirmed with vital dye staining
Abnormal Schirmer score results

Who cannot join

Eye disease that needs therapy other than that for dry eye
Those who need to wear contact lenses during the clinical study

Trial locations and contacts

1 site in 1 country.

Japan1 site

Santen study sites
Osaka, Osaka

Other trials in Japan

About this study

Official title: Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -

To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Conditions: Dry Eye
Being tested: 3% DE-089 ophthalmic solution, 0.1% sodium hyaluronate ophthalmic solution
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3% DE-089 ophthalmic solutionDrug
0.1% sodium hyaluronate ophthalmic solutionDrug

Study groups in NCT01240382
Study group	Role	What they receive
3% DE-089	Experimental	Not described Receives: Drug: 3% DE-089 ophthalmic solution
0.1% HA	Active comparator	Not described Receives: Drug: 0.1% sodium hyaluronate ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Fluorescein Staining Score From Baseline
Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.
The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.
Measured: Baseline and 4-week (discontinued (LOCF))
Mean Change in Rose Bengal Staining Score From Baseline
Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.
The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.
Measured: Baseline and 4-week (discontinued (LOCF))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

?Feb 2008

First posted15 Nov 2010 (estimated)
Primary completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Enrolment: 332 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240382
Sponsor's protocol ID: 00890602
Status last verified: Aug 2014
First submitted: 12 Nov 2010
Last updated: 13 Aug 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Takamura E, Tsubota K, Watanabe H, Ohashi Y; Diquafosol Ophthalmic Solution Phase 3 Study Group. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.
PubMed 22914501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -
ClinicalTrials.gov ID: NCT01240382
Acronym / sponsor ID: 00890602
Conditions: Dry Eye
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 332 participants (actual)
Lead sponsor: Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Primary completion: Feb 2008 (actual)
First posted: 15 Nov 2010 (estimated)
Results: Posted 8 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Number of arms: 2

Arm	Type	Receives
3% DE-089	Experimental	Drug: 3% DE-089 ophthalmic solution
0.1% HA	Active comparator	Drug: 0.1% sodium hyaluronate ophthalmic solution

Who may qualify

Ages: 20 years and older
Sex: All
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Those who show:

Key exclusion criteria (2 listed)

Eye disease that needs therapy other than that for dry eye
Those who need to wear contact lenses during the clinical study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3% DE-089 ophthalmic solution	Drug	3% DE-089
0.1% sodium hyaluronate ophthalmic solution	Drug	0.1% HA

Primary outcome

Mean Change in Fluorescein Staining Score From Baseline
Time frame: Baseline and 4-week (discontinued (LOCF))
Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.
Mean Change in Rose Bengal Staining Score From Baseline
Time frame: Baseline and 4-week (discontinued (LOCF))
Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

Results and safety

Results posted to the registry on 8 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3% DE-089	144	142
0.1% HA	143	139

Primary outcome: Mean Change in Fluorescein Staining Score From Baseline

Time frame: Baseline and 4-week (discontinued (LOCF)). Mean (Standard Deviation). Unit: points

Measure	3% DE-089 n = 144	0.1% HA n = 142
Value	-2.12 (1.66)	-2.08 (1.52)

3% DE-089 vs 0.1% HA: Median Difference (Final Values): -0.03 (95% CI -0.405 to 0.338), l

Population analysed: Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.

Primary outcome: Mean Change in Rose Bengal Staining Score From Baseline

Time frame: Baseline and 4-week (discontinued (LOCF)). Mean (Standard Deviation). Unit: points

Measure	3% DE-089 n = 144	0.1% HA n = 141
Value	-3.06 (2.27)	-2.38 (2.08)

3% DE-089 vs 0.1% HA: Median Difference (Final Values): -0.67 (95% CI -1.18 to -0.67), p = 0.010, t-test, 2 sided

Population analysed: Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3% DE-089	0 of 144 (0%)	9 of 144 (6.3%)	Not reported
0.1% HA	1 of 143 (0.7%)	1 of 143 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22914501Takamura E, Tsubota K, Watanabe H, Ohashi Y; Diquafosol Ophthalmic Solution Phase 3 Study Group. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3% DE-089 ophthalmic solution and 0.1% sodium hyaluronate ophthalmic solution in people with Dry Eye, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Fluorescein Staining Score From Baseline (time frame: Baseline and 4-week (discontinued (LOCF))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01240382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.