Non-infectious, Non-necrotizing Anterior ScleritisPhase 1NCT01059955
Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study
A Phase 1 study testing Dexamethasone Phosphate Ophthalmic Solution (EGP-437) and Dexamethasone phosphate ophthalmic solution in people with Non-infectious, Non-necrotizing Anterior Scleritis, run by John Kempen at 6 sites in United States.
Trial summary
This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infectious, Non-necrotizing Anterior Scleritis
- What is being tested?
- Dexamethasone Phosphate Ophthalmic Solution (EGP-437) and Dexamethasone phosphate ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2012to Feb 2014
- Phase
- Phase 1
- 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
- Male or female age at least 18 years
- A diagnosis of active non-infectious, non-necrotizing anterior scleritis (nodular or diffuse is acceptable)
- Not planning to undergo elective ocular surgery during the study
- Provide written informed consent
- Be able and willing to follow instructions, return for all study visits, and willing to comply with all study-related instructions
- If female and of childbearing potential; submit a urine sample and have a negative pregnancy test at Visit 1; agree to use an acceptable method of contraception during the study. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is post-menopausal (has not had a menstrual cycle for >2 years or has laboratory evidence of a post-menopausal state). Acceptable methods of contraception include: spermicide with barrier, hormonal contraception, IUD, or surgical sterilization of partner. Complete abstinence throughout the study period also is acceptable.
Who cannot join
- Contraindications to the use of the test articles
- Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., corticosteroids)
- For patients not taking systemic corticosteroids or immunosuppressants, any condition constituting conferring a likelihood that systemic corticosteroids or immunosuppressants would need to be started during the 56-day study period
- For patients already taking systemic corticosteroids and/or immunosuppressants, any condition conferring a likelihood that systemic corticosteroid or immunosuppressant dosage would need to be changed during the 56-day study period
- Intraocular pressure high enough that intraocular pressure-lowering medications are likely to be needed (≥25 mmHg or IOP>target pressure for patients with glaucoma); and/or more than two ocular anti-hypertensive medications (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt or Combigan are considered two medications)
- Glaucoma sufficiently advanced that an intraocular pressure spike would potentially put the patient at substantial risk of vision loss, per the clinician-investigator's judgment.
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- Cancer
- Subject is planning to undergo elective surgery during the study period
- Any active ocular infections (bacterial, viral, or fungal), active ocular inflammation other than scleritis (i.e., follicular conjunctivitis, iritis), or preauricular lymphadenopathy
- History or diagnosis of ocular herpes or corneal lesion of suspected herpetic origin
- Severe eyelid or ocular surface lesions impeding application of the iontophoresis applicator
- Severe / serious ocular pathology or medical condition which may preclude study completion
- Any condition conferring a likelihood that topical ophthalmic medications in use at baseline would need to be changed during the 56-day study period.
- History of Stevens-Johnson Syndrome or mucous membrane pemphigoid
- Unwilling to discontinue use of contact lenses for the duration of the study
- Any open wounds / skin disease on the forehead where the iontophoresis return electrode will be applied
- Pacemakers and/or any other electrical sensitive support system
- Any significant illness or condition that could, in the investigator's or sub-investigator's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk
- Be currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- Participation in an investigational drug or device study within 30 days of entering the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Wilmer Eye Institute/Johns Hopkins University
Baltimore, Maryland, 21287
University of Miami
Miami, Florida
Scheie Eye Institute/University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Sciences University
Portland, Oregon
University of California, San Francisco
San Francisco, California
Montefiore Medical Center
The Bronx, New York
About this study
This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued.
Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.
- Being tested
- Dexamethasone Phosphate Ophthalmic Solution (EGP-437), Dexamethasone phosphate ophthalmic solution
- Keywords
- scleritis, anterior scleritis, nodular anterior scleritis, diffuse anterior scleritis
- Medical subject headings
- Scleritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Phosphate Ophthalmic Solution (EGP-437)Drug
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only).
Dexamethasone phosphate ophthalmic solutionDrug
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
| Study group | Role | What they receive |
|---|---|---|
| Active treatment at day 0 and day 7 | Experimental | Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and one at Day 7.
The three iontophoresis doses are:
1. Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA
2. Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA
3. Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA Receives: Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437) |
| Active Treatment at Day 0, Sham Treatment at Day 7 | Active comparator | Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and a sham treatment Day 7.
The three iontophoresis doses are:
1. Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA
2. Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA
3. Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA Receives: Drug: Dexamethasone phosphate ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: 56 days
Secondary outcomes (1)
Improvement on scleritis scale score
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-infectious, Non-necrotizing Anterior ScleritisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Kempen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Kempen, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059955
- Sponsor's protocol ID
- EGP-IST-001
- Other IDs
- 1R01FD003910
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2010
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Neil EC, Huang J, Suhler EB, Dunn JP Jr, Perez VL, Gritz DC, McWilliams K, Peskin E, Ying GS, Bunya VY, Maguire MG, Kempen JH. Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. Br J Ophthalmol. 2018 Aug;102(8):1011-1013. doi: 10.1136/bjophthalmol-2017-311610. Epub 2018 Apr 17.
PubMed 29666122
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study
- ClinicalTrials.gov ID
- NCT01059955
- Acronym / sponsor ID
- EGP-IST-001
- Keywords
- scleritis, anterior scleritis, nodular anterior scleritis, diffuse anterior scleritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- John KempenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Feb 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.
This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued.
Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment at day 0 and day 7 | Experimental | Drug: Dexamethasone Phosphate Ophthalmic Solution (EGP-437)Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and one at Day 7. The three iontophoresis doses are: 1. Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA 2. Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA 3. Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA |
| Active Treatment at Day 0, Sham Treatment at Day 7 | Active comparator | Drug: Dexamethasone phosphate ophthalmic solutionIontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and a sham treatment Day 7. The three iontophoresis doses are: 1. Ocular iontophoresis with EGP-437 1.2 mA-min at 0.4 mA 2. Ocular iontophoresis with EGP-437 2.5 mA-min at 0.8 mA 3. Ocular iontophoresis with EGP-437 4.5 mA-min at 1.5 mA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female age at least 18 years
- A diagnosis of active non-infectious, non-necrotizing anterior scleritis (nodular or diffuse is acceptable)
- Not planning to undergo elective ocular surgery during the study
- Provide written informed consent
- Be able and willing to follow instructions, return for all study visits, and willing to comply with all study-related instructions
Key exclusion criteria (20 listed)
- Contraindications to the use of the test articles
- Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., corticosteroids)
- For patients not taking systemic corticosteroids or immunosuppressants, any condition constituting conferring a likelihood that systemic corticosteroids or immunosuppressants would need to be started during the 56-day study period
- For patients already taking systemic corticosteroids and/or immunosuppressants, any condition conferring a likelihood that systemic corticosteroid or immunosuppressant dosage would need to be changed during the 56-day study period
- Intraocular pressure high enough that intraocular pressure-lowering medications are likely to be needed (≥25 mmHg or IOP>target pressure for patients with glaucoma); and/or more than two ocular anti-hypertensive medications (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt or Combigan are considered two medications)
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 |
|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution (EGP-437)Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only). | Drug | Active treatment at day 0 and day 7 |
| Dexamethasone phosphate ophthalmic solutionTranscleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only) | Drug | Active Treatment at Day 0, Sham Treatment at Day 7 |
Primary outcome
Dose-limiting toxicity
Time frame: 56 days
1 secondary outcome
Improvement on scleritis scale score
Time frame: 56 days
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 Apr 2016.
- Derived from this study: PubMed 29666122O'Neil EC, Huang J, Suhler EB, Dunn JP Jr, Perez VL, Gritz DC, McWilliams K, Peskin E, Ying GS, Bunya VY, Maguire MG, Kempen JH. Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. Br J Ophthalmol. 2018 Aug;102(8):1011-1013. doi: 10.1136/bjophthalmol-2017-311610. Epub 2018 Apr 17.
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 1 study testing Dexamethasone Phosphate Ophthalmic Solution (EGP-437) and Dexamethasone phosphate ophthalmic solution in people with Non-infectious, Non-necrotizing Anterior Scleritis, run by John Kempen at 6 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 6 inclusion and 20 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 Apr 2016. 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 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. 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 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.
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?
Dose-limiting toxicity (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059955, which also lists 1 linked publication.
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 Apr 2016.