Persistent Corneal Epithelial DefectPhase 2NCT00988494
Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
A Phase 2 study testing DE-105 ophthalmic solution in people with Persistent Corneal Epithelial Defect, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Persistent Corneal Epithelial Defect
- What is being tested?
- DE-105 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2009to not given
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has corneal epithelial defect and decreased corneal sensitivity.
- Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.
Who cannot join
- Presence of disease such as active ocular infection, or abnormal lid closure.
- History or presence of chemical burn, Stevens - Johnson Syndrome, etc.
- History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.
- Conditions
- Persistent Corneal Epithelial Defect
- Being tested
- DE-105 ophthalmic solution, Placebo ophthalmic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-105 ophthalmic solutionDrug
Topical ocular application
DE-105 ophthalmic solutionDrug
Topical ocular application
Placebo ophthalmic solutionDrug
Topical ocular application
| Study group | Role | What they receive |
|---|---|---|
| High concentration | Experimental | DE-105 high concentration Receives: Drug: DE-105 ophthalmic solution |
| Low concentration | Experimental | DE-105 low concentration Receives: Drug: DE-105 ophthalmic solution |
| Placebo | Placebo comparator | DE-105 placebo Receives: Drug: Placebo ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of corneal epithelial defect
Measured: Every week
Secondary outcomes (1)
Visual acuity,etc.
Measured: Exit visit,etc.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Corneal Epithelial DefectStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988494
- Sponsor's protocol ID
- 01050807
- Status last verified
- Nov 2012
- First submitted
- 30 Sep 2009
- Last updated
- 22 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
- ClinicalTrials.gov ID
- NCT00988494
- Acronym / sponsor ID
- 01050807
- Conditions
- Persistent Corneal Epithelial Defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- First posted
- 2 Oct 2009 (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-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High concentration | Experimental | Drug: DE-105 ophthalmic solutionDE-105 high concentration |
| Low concentration | Experimental | Drug: DE-105 ophthalmic solutionDE-105 low concentration |
| Placebo | Placebo comparator | Drug: Placebo ophthalmic solutionDE-105 placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Has corneal epithelial defect and decreased corneal sensitivity.
- Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.
Key exclusion criteria (3 listed)
- Presence of disease such as active ocular infection, or abnormal lid closure.
- History or presence of chemical burn, Stevens - Johnson Syndrome, etc.
- History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.
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 |
|---|---|---|
| DE-105 ophthalmic solutionTopical ocular application | Drug | High concentration |
| DE-105 ophthalmic solutionTopical ocular application | Drug | Low concentration |
| Placebo ophthalmic solutionTopical ocular application | Drug | Placebo |
Primary outcome
Restoration of corneal epithelial defect
Time frame: Every week
1 secondary outcome
Visual acuity,etc.
Time frame: Exit visit,etc.
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 22 Nov 2012.
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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 DE-105 ophthalmic solution in people with Persistent Corneal Epithelial Defect, 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 2 inclusion and 3 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 22 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 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. Some participants in this study may receive a placebo. 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?
Restoration of corneal epithelial defect (time frame: Every week). 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 22 Nov 2012; AzTrials last refreshed its copy on 4 Nov 2026.