Dry EyeNCT01101984
Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
A study testing diquafosol ophthalmic solution and 0.1% sodium hyaluronate ophthalmic solution. in people with Dry Eye, run by Santen Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
Trial summary
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- diquafosol ophthalmic solution and 0.1% sodium hyaluronate ophthalmic solution.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 69 years
- All sexes
- No healthy volunteers
- 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
2 sites in 2 countries.
2 sites in 2 countries
Singapore1 site
Singapore Eye Research Institute
Singapore, Singapore, 168751
About this study
Official title: A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.
- Conditions
- Dry Eye
- Being tested
- diquafosol 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.
diquafosol ophthalmic solutionDrug
Also called HA
DE-089 topical ocular application, 6 times daily for 4 weeks.
0.1% sodium hyaluronate ophthalmic solution.Drug
0.1% HA topical ocular application, 6 times daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DE-089 | Experimental | DE-089 ophthalmic solution Receives: Drug: diquafosol ophthalmic solution; Drug: 0.1% sodium hyaluronate ophthalmic solution. |
| HA | Active comparator | 0.1% sodium hyaluronate ophthalmic solution 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.
Changes in the fluorescein and rose bengal staining score
- Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority)
- Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)
Measured: 2 weeks and 4 weeks from baseline.
Secondary outcomes (1)
Changes in tear film breakup time (second)
Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation
Measured: 2 weeks and 4 weeks from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startFeb 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101984
- Sponsor's protocol ID
- 08901
- Status last verified
- Nov 2012
- First submitted
- 7 Apr 2010
- Last updated
- 14 Nov 2012
- Results posted
- No
Publications
Gong L, Sun X, Ma Z, Wang Q, Xu X, Chen X, Shao Y, Yao K, Tang L, Gu Y, Yuan H, Chua WH, Chuan JC, Tong L. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore. Br J Ophthalmol. 2015 Jul;99(7):903-8. doi: 10.1136/bjophthalmol-2014-306084. Epub 2015 Jan 28.
PubMed 25631485
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -
- ClinicalTrials.gov ID
- NCT01101984
- Acronym / sponsor ID
- 08901
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DE-089 | Experimental | Drug: diquafosol ophthalmic solution, Drug: 0.1% sodium hyaluronate ophthalmic solution.DE-089 ophthalmic solution |
| HA | Active comparator | Drug: 0.1% sodium hyaluronate ophthalmic solution.0.1% sodium hyaluronate ophthalmic solution |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 |
|---|---|---|
| diquafosol ophthalmic solutionAlso: HADE-089 topical ocular application, 6 times daily for 4 weeks. | Drug | DE-089 |
| 0.1% sodium hyaluronate ophthalmic solution.0.1% HA topical ocular application, 6 times daily for 4 weeks. | Drug | DE-089, HA |
Primary outcome
Changes in the fluorescein and rose bengal staining score
Time frame: 2 weeks and 4 weeks from baseline.
1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) 2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)
1 secondary outcome
Changes in tear film breakup time (second)
Time frame: 2 weeks and 4 weeks from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Derived from this study: PubMed 25631485Gong L, Sun X, Ma Z, Wang Q, Xu X, Chen X, Shao Y, Yao K, Tang L, Gu Y, Yuan H, Chua WH, Chuan JC, Tong L. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore. Br J Ophthalmol. 2015 Jul;99(7):903-8. doi: 10.1136/bjophthalmol-2014-306084. Epub 2015 Jan 28.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diquafosol ophthalmic solution and 0.1% sodium hyaluronate ophthalmic solution. in people with Dry Eye, run by Santen Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
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 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Singapore. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the fluorescein and rose bengal staining score (time frame: 2 weeks and 4 weeks from baseline.). 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 NCT01101984, 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 14 Nov 2012.