Dry Eye DiseasePhase 2NCT00760045
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
A Phase 2 study testing Hydroxypropyl Guar Galactomannan and 0.1% sodium hyaluronate ophthalmic solution in people with Dry Eye Disease, run by Alcon Research at 1 site in Japan.
Trial summary
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Hydroxypropyl Guar Galactomannan and 0.1% sodium hyaluronate ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to Oct 2008
- Phase
- Phase 2
- 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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.
Who cannot join
- Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye.
- Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka Pharmacology Clinical Research Hospital
Osaka, Osaka, 532-0003
About this study
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.
- Conditions
- Dry Eye Disease
- Being tested
- Hydroxypropyl Guar Galactomannan, 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.
Hydroxypropyl Guar GalactomannanDrug
One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
0.1% sodium hyaluronate ophthalmic solutionDrug
One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AL-43546 0.15% Receives: Drug: Hydroxypropyl Guar Galactomannan |
| 2 | Experimental | AL-43546 0.25% Receives: Drug: Hydroxypropyl Guar Galactomannan |
| 3 | Active comparator | AL-43546 0%(Vehicle) Receives: Drug: Hydroxypropyl Guar Galactomannan |
| 4 | Active comparator | 0.1% sodium hyaluronate ophthalmic solutio 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.
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
Measured: Up to 180 minutes
Secondary outcomes (1)
Ocular comfort
Measured: After installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760045
- Sponsor's protocol ID
- C-07-54
- Status last verified
- Jan 2010
- First submitted
- 24 Sep 2008
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
- ClinicalTrials.gov ID
- NCT00760045
- Acronym / sponsor ID
- C-07-54
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 25 Sep 2008 (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.
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Hydroxypropyl Guar GalactomannanAL-43546 0.15% |
| 2 | Experimental | Drug: Hydroxypropyl Guar GalactomannanAL-43546 0.25% |
| 3 | Active comparator | Drug: Hydroxypropyl Guar GalactomannanAL-43546 0%(Vehicle) |
| 4 | Active comparator | Drug: 0.1% sodium hyaluronate ophthalmic solution0.1% sodium hyaluronate ophthalmic solutio |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.
Key exclusion criteria (2 listed)
- Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye.
- Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.
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 |
|---|---|---|
| Hydroxypropyl Guar GalactomannanOne drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods. | Drug | 1, 2, 3 |
| 0.1% sodium hyaluronate ophthalmic solutionOne drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods. | Drug | 4 |
Primary outcome
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
Time frame: Up to 180 minutes
1 secondary outcome
Ocular comfort
Time frame: After installation
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 6 Jan 2010.
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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 2 study testing Hydroxypropyl Guar Galactomannan and 0.1% sodium hyaluronate ophthalmic solution in people with Dry Eye Disease, run by Alcon Research 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 1 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 6 Jan 2010. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). (time frame: Up to 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2010.