Dry EyePhase 2NCT01239069
Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
A Phase 2 study testing DE-110 ophthalmic suspension high dose and DE-110 ophthalmic suspension low dose in people with Dry Eye, run by Santen Inc. at 14 sites in United States.
Trial summary
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment 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-110 ophthalmic suspension high dose and DE-110 ophthalmic suspension low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2010to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of dry eye
- Not wear contact lenses during study
- 18 years or older
- Understand and provide written consent
- Negative pregnancy test and use acceptable method of contraception
Who cannot join
- Use of any topical ocular medication
- Any type of ocular surgery
- Diagnosis of on-going ocular infection and/or allergic conjunctivitis
- Uncontrolled systemic conditions/lid abnormalities
- Corneal transplants
- Females who are pregnant, nursing or planning a pregnancy
- Participation in another drug trial concurrently or within 30 days prior to study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Bangor, Maine
Study site
Bloomfield, Connecticut
Study site
Bradenton, Florida
Study site
Brooksville, Florida
Study site
Cleveland, Ohio
Study site
Inglewood, California
Study site
Largo, Florida
Study site
Louisville, Kentucky
Study site
Newport Beach, California
Study site
Norfolk, Virginia
Study site
Petaluma, California
Study site
Rosewell, Georgia
Study site
San Antonio, Texas
Study site
Torrance, California
About this study
Official title: A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease
- Conditions
- Dry Eye
- Being tested
- DE-110 ophthalmic suspension high dose, DE-110 ophthalmic suspension low dose, Placebo
- 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-110 ophthalmic suspension high doseDrug
ophthalmic suspension; high dose; QID
DE-110 ophthalmic suspension low doseDrug
ophthalmic suspension; low dose; QID
PlaceboOther
DE-110 ophthalmic suspension vehicle;QID
| Study group | Role | What they receive |
|---|---|---|
| DE-110 ophthalmic suspension high dose | Experimental | Not described Receives: Drug: DE-110 ophthalmic suspension high dose |
| DE-110 ophthalmic suspension low dose | Experimental | Not described Receives: Drug: DE-110 ophthalmic suspension low dose |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of DE-110
Measured: 12 weeks
Secondary outcomes (3)
Individual Response Rate
Measured: 12 weeks
Individual Efficacy
Measured: 12 weeks
Individual Symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239069
- Sponsor's protocol ID
- 30-002
- Status last verified
- May 2014
- First submitted
- 9 Nov 2010
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01239069
- Acronym / sponsor ID
- 30-002
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Nov 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.
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DE-110 ophthalmic suspension high dose | Experimental | Drug: DE-110 ophthalmic suspension high dose |
| DE-110 ophthalmic suspension low dose | Experimental | Drug: DE-110 ophthalmic suspension low dose |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of dry eye
- Not wear contact lenses during study
- 18 years or older
- Understand and provide written consent
- Negative pregnancy test and use acceptable method of contraception
Key exclusion criteria (7 listed)
- Use of any topical ocular medication
- Any type of ocular surgery
- Diagnosis of on-going ocular infection and/or allergic conjunctivitis
- Uncontrolled systemic conditions/lid abnormalities
- 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-110 ophthalmic suspension high doseophthalmic suspension; high dose; QID | Drug | DE-110 ophthalmic suspension high dose |
| DE-110 ophthalmic suspension low doseophthalmic suspension; low dose; QID | Drug | DE-110 ophthalmic suspension low dose |
| PlaceboDE-110 ophthalmic suspension vehicle;QID | Other | Placebo |
Primary outcome
Efficacy of DE-110
Time frame: 12 weeks
3 secondary outcomes
Individual Response Rate
Time frame: 12 weeks
Individual Efficacy
Time frame: 12 weeks
Individual Symptoms
Time frame: 12 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 21 May 2014.
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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.
14 sites 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-110 ophthalmic suspension high dose and DE-110 ophthalmic suspension low dose in people with Dry Eye, run by Santen Inc. at 14 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 5 inclusion and 7 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 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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?
Efficacy of DE-110 (time frame: 12 weeks). 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 21 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.