Cataract SurgeryPhase 3NCT02573610
Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
A Phase 3 study testing DE-108 and Levofloxacin 0.5% in people with Cataract Surgery, run by Santen Pharmaceutical Co., Ltd. at 6 sites in South Korea.
Trial summary
The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- DE-108 and Levofloxacin 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 21 Sep 2015to 31 Mar 2017
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are scheduled for cataract surgery
Who cannot join
- Those who with suspected ocular infections based on clinical findings in the study eye.
- Those who have any eye disease other than cataract which requires treatment in the target eye.
- Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine)
- Those who need to wear contact lenses during the study period
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Kyungpook National University Hospital
Kyungpook
Asan Medical Center
Seoul
Kim's eye Hospital
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul Saint Marry's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -
The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.
- Conditions
- Cataract Surgery
- Being tested
- DE-108, Levofloxacin 0.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-108Drug
Also called Levofloxacin
Subjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.
Levofloxacin 0.5%Drug
Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| DE-108 | Experimental | High concentration / Antibacterial Ophthalmic Solution Receives: Drug: DE-108 |
| Levofloxacin 0.5% | Active comparator | Low concentration / Antibacterial Ophthalmic Solution Receives: Drug: Levofloxacin 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
Measured: 3 days (Day -3 to Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start21 Sep 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573610
- Sponsor's protocol ID
- DE-108
- Status last verified
- Oct 2017
- First submitted
- 7 Oct 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -
- ClinicalTrials.gov ID
- NCT02573610
- Acronym / sponsor ID
- DE-108
- Conditions
- Cataract Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 12 Oct 2015 (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 this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DE-108 | Experimental | Drug: DE-108High concentration / Antibacterial Ophthalmic Solution |
| Levofloxacin 0.5% | Active comparator | Drug: Levofloxacin 0.5%Low concentration / Antibacterial Ophthalmic Solution |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who are scheduled for cataract surgery
Key exclusion criteria (4 listed)
- Those who with suspected ocular infections based on clinical findings in the study eye.
- Those who have any eye disease other than cataract which requires treatment in the target eye.
- Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine)
- Those who need to wear contact lenses 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 |
|---|---|---|
| DE-108Also: LevofloxacinSubjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery. | Drug | DE-108 |
| Levofloxacin 0.5%Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery. | Drug | Levofloxacin 0.5% |
Primary outcome
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
Time frame: 3 days (Day -3 to Day0)
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 12 Oct 2017.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DE-108 and Levofloxacin 0.5% in people with Cataract Surgery, run by Santen Pharmaceutical Co., Ltd. at 6 sites in South Korea.
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 4 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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?
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?
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) (time frame: 3 days (Day -3 to Day0)). 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 12 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.