Dry EyePhase 1/2NCT01118754
Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
A Phase 1/2 study testing DE-101 ophthalmic suspension in people with Dry Eye, run by Santen Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- DE-101 ophthalmic suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of dry eye defined by protocol
- 18 years or older, and sign written informed consent
- negative pregnancy test and utilizing reliable contraceptive throughout study
Who cannot join
- use of any topical ocular medications
- any ocular surgery within 90 days of study
- laser refractive surgery within one year of study
- ocular, lid disease/abnormalities that may interfere with the study
- corneal transplants
- uncontrolled systemic conditions
- females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- participated in another drug trial within 30 days prior to study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Bangor, Maine
Study site
Bloomfield, Connecticut
Study site
Cleveland, Ohio
Study site
Gretna, Louisiana
Study site
Indianapolis, Indiana
Study site
Inglewood, California
Study site
New Albany, Indiana
Study site
Philadelphia, Pennsylvania
Study site
San Antonio, Texas
Study site
Torrance, California
About this study
Official title: Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.
- Conditions
- Dry Eye
- Being tested
- DE-101 ophthalmic suspension, DE-101 ophthalmic suspension vehicle
- Keywords
- Santen, Dry, Eye
- 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.
DE-101 ophthalmic suspensionDrug
Ophthalmic suspention; QID
DE-101 ophthalmic suspensionDrug
Ophthalmic suspension; QID
DE-101 ophthalmic suspension vehicleDrug
ophthalmic suspension vehicle; QID
| Study group | Role | What they receive |
|---|---|---|
| DE-101 ophthalmic suspension high dose | Experimental | Not described Receives: Drug: DE-101 ophthalmic suspension |
| DE-101 ophthalmic suspension low dose | Experimental | Not described Receives: Drug: DE-101 ophthalmic suspension |
| DE-101 ophthalmic suspension vehicle | Placebo comparator | Not described Receives: Drug: DE-101 ophthalmic suspension; Drug: DE-101 ophthalmic suspension vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fluorescein corneal staining
Measured: 8 weeks
Ocular Symptom Severity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118754
- Sponsor's protocol ID
- 26-004
- Status last verified
- Nov 2011
- First submitted
- 29 Apr 2010
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01118754
- Acronym / sponsor ID
- 26-004
- Conditions
- Dry Eye
- Keywords
- Santen, Dry, Eye
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 May 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.
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DE-101 ophthalmic suspension high dose | Experimental | Drug: DE-101 ophthalmic suspension |
| DE-101 ophthalmic suspension low dose | Experimental | Drug: DE-101 ophthalmic suspension |
| DE-101 ophthalmic suspension vehicle | Placebo comparator | Drug: DE-101 ophthalmic suspension, Drug: DE-101 ophthalmic suspension vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed diagnosis of dry eye defined by protocol
- 18 years or older, and sign written informed consent
- negative pregnancy test and utilizing reliable contraceptive throughout study
Key exclusion criteria (8 listed)
- use of any topical ocular medications
- any ocular surgery within 90 days of study
- laser refractive surgery within one year of study
- ocular, lid disease/abnormalities that may interfere with the study
- corneal transplants
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-101 ophthalmic suspensionOphthalmic suspention; QID | Drug | DE-101 ophthalmic suspension high dose, DE-101 ophthalmic suspension low dose, DE-101 ophthalmic suspension vehicle |
| DE-101 ophthalmic suspensionOphthalmic suspension; QID | Drug | DE-101 ophthalmic suspension low dose |
| DE-101 ophthalmic suspension vehicleophthalmic suspension vehicle; QID | Drug | DE-101 ophthalmic suspension vehicle |
Primary outcome
Total fluorescein corneal staining
Time frame: 8 weeks
Ocular Symptom Severity
Time frame: 8 weeks
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 3 Nov 2011.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DE-101 ophthalmic suspension in people with Dry Eye, run by Santen Inc. at 10 sites in United States.
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 8 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 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Total fluorescein corneal staining (time frame: 8 weeks). 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?
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 3 Nov 2011.