Dry EyePhase 1/2NCT02975557
Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)
A Phase 1/2 study testing Brimonidine 0.15% and Brimonidine 0.075% in people with Dry Eye and Ocular Graft vs Host Disease, run by Sandeep Jain, MD at 2 sites in United States.
Trial summary
The objective of this study is to establish whether patients with dry eye disease (DED) are able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine 0.15% topical eye drop solution in treating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Ocular Graft vs Host Disease, Meibomian Gland Dysfunction
- What is being tested?
- Brimonidine 0.15% and Brimonidine 0.075%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to 13 Apr 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years or older.
- Capable of giving informed consent and does provide informed consent.
- Diagnosis of Meibomian Gland Disease
- Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. If the test is positive, the participant will be discontinued from the study immediately.
Who cannot join
- Allergic to Brimonidine or any similar products, or excipients of Brimonidine
- Currently receiving any Brimonidine preparation as a part of glaucoma management
- Receiving or have received within 30 days any experimental systemic medication.
- Active ocular infection or ocular allergies.
- Any history of eyelid surgery or ocular surgery within the past 3 months.
- Corneal epithelial defect larger than 1 mm2 in either eye.
- Have active drug/alcohol dependence or abuse history.
- Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, 60612
Translational Clinic of Corneal Neurobiology Laboratory, Illinois Eye and Ear Infirmary, University of Illinois
Chicago, Illinois, 60612
About this study
Official title: A Phase I/II Randomized, Placebo-Controlled, Double-Blind, Single-Center, Tolerability And Preliminary Efficacy Study Of Use of Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)
The objective of this study is to establish whether patients with dry eye disease (DED) are able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine 0.15% topical eye drop solution in treating Meibomian Gland Dysfunction (MGD) (primary efficacy objective).
Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.
- Being tested
- Brimonidine 0.15%, Brimonidine 0.075%, Placebo
- Keywords
- Brimonidine, Dry Eye, oGVHD, MGD
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine 0.15%Drug
Also called Alphagan P
Brimonidine 0.15% eye drops 2 times a day for 12 weeks
Brimonidine 0.075%Drug
Also called Alphagan P
Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.
PlaceboDrug
Also called Refresh plus Artificial Tear
Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine 0.15% | Active comparator | Brimonidine 0.15% eye drops 2 times a day for 12 weeks Receives: Drug: Brimonidine 0.15% |
| Brimonidine 0.075% | Active comparator | Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks. Receives: Drug: Brimonidine 0.075% |
| Placebo | Placebo comparator | Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.
Subjects assessed their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end and marks at an equal distance starting from 0 mm and leading up to 100 mm (0 10 20 30 40 50 60 70 80 90 100). The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), week 3, week 6, week 9 and week 12. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
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 posted29 Nov 2016 (estimated)
- Study startMay 2016
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
Why it stopped: Slow accrual of subjects. May take longer than expected to complete the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandeep Jain, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ocugen
- Responsible party
- Sponsor-investigator, Sandeep Jain, MD, University of Illinois Chicago
- Investigators
- Sandeep Jain, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975557
- Sponsor's protocol ID
- 2015-0278
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2016
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844.
PubMed 24255046Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430.
PubMed 23169882
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Placebo-Controlled, Double-Blind, Single-Center, Tolerability And Preliminary Efficacy Study Of Use of Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)
- ClinicalTrials.gov ID
- NCT02975557
- Acronym / sponsor ID
- 2015-0278
- Keywords
- Brimonidine, Dry Eye, oGVHD, MGD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual of subjects. May take longer than expected to complete the trial.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sandeep Jain, MDUniversity, hospital or other
- Collaborators
- Ocugen
- Study start
- May 2016 (actual)
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to establish whether patients with dry eye disease (DED) are able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine 0.15% topical eye drop solution in treating Meibomian Gland Dysfunction (MGD) (primary efficacy objective).
Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brimonidine 0.15% | Active comparator | Drug: Brimonidine 0.15%Brimonidine 0.15% eye drops 2 times a day for 12 weeks |
| Brimonidine 0.075% | Active comparator | Drug: Brimonidine 0.075%Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older.
- Capable of giving informed consent and does provide informed consent.
- Diagnosis of Meibomian Gland Disease
- Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. If the test is positive, the participant will be discontinued from the study immediately.
Key exclusion criteria (8 listed)
- Allergic to Brimonidine or any similar products, or excipients of Brimonidine
- Currently receiving any Brimonidine preparation as a part of glaucoma management
- Receiving or have received within 30 days any experimental systemic medication.
- Active ocular infection or ocular allergies.
- Any history of eyelid surgery or ocular surgery within the past 3 months.
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 |
|---|---|---|
| Brimonidine 0.15%Also: Alphagan PBrimonidine 0.15% eye drops 2 times a day for 12 weeks | Drug | Brimonidine 0.15% |
| Brimonidine 0.075%Also: Alphagan PBrimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks. | Drug | Brimonidine 0.075% |
| PlaceboAlso: Refresh plus Artificial TearPlacebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks. | Drug | Placebo |
Primary outcome
Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.
Time frame: 12 weeks
Subjects assessed their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end and marks at an equal distance starting from 0 mm and leading up to 100 mm (0 10 20 30 40 50 60 70 80 90 100). The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), week 3, week 6, week 9 and week 12. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24255046Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844.
- Background: PubMed 23169882Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430.
- Principal Investigator descriptionLink provided by the sponsor.
- Dry Eye and ocular GVHD Clinic at University of Illinois at ChicagoLink provided by the sponsor.
- Corneal Neurobiology Laboratory (National Eye Institute funded)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sandeep Jain, MD principal investigator
University of Illinois Chicago
2 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 Brimonidine 0.15% and Brimonidine 0.075% in people with Dry Eye and Ocular Graft vs Host Disease, run by Sandeep Jain, MD at 2 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 4 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: stopped early, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks. (time frame: 12 weeks). 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 NCT02975557, which also lists 2 linked publications.
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 8 Nov 2019.