Open-angle Glaucoma or Ocular HypertensionPhase 2NCT01868126
Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
A Phase 2 study testing DE-117 ophthalmic solution and latanoprost ophthalmic solution in people with Open-angle Glaucoma or Ocular Hypertension, run by Santen Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma or Ocular Hypertension
- What is being tested?
- DE-117 ophthalmic solution and latanoprost ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2013to Sep 2013
- 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
Main Inclusion Criteria:
- Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- Qualifying intraocular pressure in at least one eye at Baseline
- Qualifying corrected ETDRS visual acuity in each eye
- Qualifying central cornea thickness in each eye
Main Exclusion Criteria:
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
- Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
- History of ocular surgery specifically intended to lower IOP
- History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
- Intended or current use of any ocular medications other than study medications during the study
- Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
- Known allergy or sensitivity to any components of the study medications
- Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
- Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
- Females who are pregnant, nursing or planning a pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Austin, Texas, 78731
Study site
Cleveland, Ohio, 44115
Study site
Kansas City, Missouri, 64133
Study site
Morrow, Georgia, 30260
Study site
Newport Beach, California, 92663
Study site
Rochester, New York, 14618
Study site
San Antonio, Texas, 78240
About this study
Official title: A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
Read the detailed description
This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.
- Being tested
- DE-117 ophthalmic solution, latanoprost ophthalmic solution, Placebo
- Keywords
- Santen, Eye, Glaucoma, Ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-117 ophthalmic solutionDrug
latanoprost ophthalmic solutionDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1: DE-117 ophthalmic solution | Experimental | One drop DE-117 Low Dose in each eye daily for 28 days Receives: Drug: DE-117 ophthalmic solution |
| Group 2: DE-117 ophthalmic solution | Experimental | One drop DE-117 Low Middle Dose in each eye daily for 28 days Receives: Drug: DE-117 ophthalmic solution |
| Group 3: DE-117 ophthalmic solution | Experimental | One drop DE-117 High Middle Dose in each eye daily for 28 days Receives: Drug: DE-117 ophthalmic solution |
| Group 4: DE-117 ophthalmic solution | Experimental | One drop DE-117 High Dose in each eye daily for 28 days Receives: Drug: DE-117 ophthalmic solution |
| latanoprost ophthalmic solution | Active comparator | One drop latanoprost 0.005% in each eye daily for 28 days Receives: Drug: latanoprost ophthalmic solution |
| placebo (vehicle of DE-117) ophthalmic solution | Placebo comparator | One drop DE-117 vehicle in each eye once daily for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (mmHg)
Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry
Measured: Day 1, Day 8, Day 15 and Day 29
Secondary outcomes (2)
Adverse events
Adverse events will be assessed at each visit to evaluate safety
Measured: Day 1, Day 8, Day 15 and Day 29
Ocular signs and symptoms
Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry
Measured: Day 1, Day 8, Day 15 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle Glaucoma or Ocular HypertensionStudies 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
- 91 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
- NCT01868126
- Sponsor's protocol ID
- 33-002
- Status last verified
- Apr 2018
- First submitted
- 29 May 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01868126
- Acronym / sponsor ID
- 33-002
- Keywords
- Santen, Eye, Glaucoma, Ocular hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Jun 2013 (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 investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
Detailed description
This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: DE-117 ophthalmic solution | Experimental | Drug: DE-117 ophthalmic solutionOne drop DE-117 Low Dose in each eye daily for 28 days |
| Group 2: DE-117 ophthalmic solution | Experimental | Drug: DE-117 ophthalmic solutionOne drop DE-117 Low Middle Dose in each eye daily for 28 days |
| Group 3: DE-117 ophthalmic solution | Experimental | Drug: DE-117 ophthalmic solutionOne drop DE-117 High Middle Dose in each eye daily for 28 days |
| Group 4: DE-117 ophthalmic solution | Experimental | Drug: DE-117 ophthalmic solutionOne drop DE-117 High Dose in each eye daily for 28 days |
| latanoprost ophthalmic solution | Active comparator | Drug: latanoprost ophthalmic solutionOne drop latanoprost 0.005% in each eye daily for 28 days |
| placebo (vehicle of DE-117) ophthalmic solution | Placebo comparator | Other: PlaceboOne drop DE-117 vehicle in each eye once daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-117 ophthalmic solution | Drug | Group 1: DE-117 ophthalmic solution, Group 2: DE-117 ophthalmic solution, Group 3: DE-117 ophthalmic solution, Group 4: DE-117 ophthalmic solution |
| latanoprost ophthalmic solution | Drug | latanoprost ophthalmic solution |
| Placebo | Other | placebo (vehicle of DE-117) ophthalmic solution |
Primary outcome
Intraocular pressure (mmHg)
Time frame: Day 1, Day 8, Day 15 and Day 29
Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry
2 secondary outcomes
Adverse events
Time frame: Day 1, Day 8, Day 15 and Day 29
Ocular signs and symptoms
Time frame: Day 1, Day 8, Day 15 and Day 29
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 18 Apr 2018.
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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.
7 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-117 ophthalmic solution and latanoprost ophthalmic solution in people with Open-angle Glaucoma or Ocular Hypertension, run by Santen Inc. at 7 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?
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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Intraocular pressure (mmHg) (time frame: Day 1, Day 8, Day 15 and Day 29). 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 18 Apr 2018.