Dry Eye DiseasePhase 2NCT01468168
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
A Phase 2 study testing DE-101 Ophthalmic Suspension in people with Dry Eye Disease, run by Santen Inc. at 13 sites in United States.
Trial summary
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- DE-101 Ophthalmic Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2011to Nov 2012
- 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
- Individuals considered for entry into the study will be of either sex and any race who have:
- a confirmed diagnosis of dry eye,
- are willing to use no ocular treatments during the study other than study medication,
- have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
- will not use contact lenses during the study,
- Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
- 18 years of age or older,
- able to understand and provide written informed consent
Who cannot join
- Subjects with any of the following are not eligible to participate in the study:
- Fluorescein corneal staining or conjunctival staining that is too severe
- Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
- Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
- Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
- Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
Show all 15Show fewer
- Ocular(including lid)disease/abnormality that may interfere with the study
- Corneal transplant in either eye, at any time prior to enrollment in the study
- Laser refractive surgery less than one year prior to Visit 1 (Day 1)
- Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
- Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
- Known allergy or sensitivity to any of the study medication components
- Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
- A woman who is pregnant, nursing, or planning a pregnancy
- Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Bangor, Maine, 04401
Study site
Cleveland, Ohio, 44115
Study site
High Point, North Carolina, 27262
Study site
Kansas City, Missouri, 64111
Study site
Largo, Florida, 33773
Study site
Morrow, Georgia, 30260
Study site
New Port Beach, California, 92663
Study site
Norfolk, Virginia, 23507
Study site
Parker, Colorado, 80134
Study site
Roswell, Georgia, 30076
Study site
Salt Lake City, Utah, 84107
Study site
St Louis, Missouri, 63131
Study site
Washington, Missouri, 63090
About this study
Official title: A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- DE-101 Ophthalmic Suspension, DE-101 Ophthalmic Suspension Vehicle
- 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 suspension; 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 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear volume increase from baseline
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 183 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
- NCT01468168
- Sponsor's protocol ID
- 26-005
- Status last verified
- Dec 2012
- First submitted
- 7 Nov 2011
- Last updated
- 17 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01468168
- Acronym / sponsor ID
- 26-005
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Nov 2011 (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.
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in 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 Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals considered for entry into the study will be of either sex and any race who have:
- a confirmed diagnosis of dry eye,
- are willing to use no ocular treatments during the study other than study medication,
- have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
- will not use contact lenses during the study,
Key exclusion criteria (15 listed)
- Subjects with any of the following are not eligible to participate in the study:
- Fluorescein corneal staining or conjunctival staining that is too severe
- Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
- Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
- Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
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 suspension; QID | Drug | DE-101 Ophthalmic Suspension High Dose |
| 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
Tear volume increase from baseline
Time frame: baseline and 6 months
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 17 Dec 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.
13 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-101 Ophthalmic Suspension in people with Dry Eye Disease, run by Santen Inc. at 13 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 8 inclusion and 15 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Tear volume increase from baseline (time frame: baseline and 6 months). 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 17 Dec 2012.