Meibomian Gland DysfunctionPhase 2NCT01633788
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
A Phase 2 study testing AGN-195263 0.1%, AGN-195263 0.03% and AGN-195263 0.01% in people with Meibomian Gland Dysfunction, run by Allergan at 33 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- AGN-195263 0.1%, AGN-195263 0.03% and AGN-195263 0.01%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 33 sitesUnited States
- Study dates
- 22 Aug 2012to 5 Feb 2015
- Phase
- Phase 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meibomian gland dysfunction in both eyes
- Best-corrected visual acuity of 20/40 or better in each eye
Who cannot join
- Known or suspected prostate cancer
- History of breast cancer
- Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
- Contact lens wear in either eye during any portion of the study
- Unable to instill eye drops correctly
- History of corneal refractive surgery in either eye within 1 year
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Sall Research Medical Center
Artesia, California, 90701
Wohl Eye Center
Bloomingdale, Illinois, 60108
The Eye Associates of Manatee, LLP
Bradenton, Florida, 34209
Vision Center of Texas, PA
Cedar Park, Texas, 78613
Centennial Eye Associates
Centennial, Colorado, 80112
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Colorado Eye Associates, PC
Colorado Springs, Colorado, 80907
Danbury Eye Physicians & Surgeons, PC
Danbury, Connecticut, 06810
Drs. Fine, Hoffman, and Packer, LLC
Eugene, Oregon, 97401
Orange County Ophthalmology Medical Group, Inc.
Garden Grove, California, 92843
Lugene Eye Institute
Glendale, California, 91205
Cornerstone Eye Care
High Point, North Carolina, 27262
University of Houston, College of Optometry
Houston, Texas, 77204
Lakeside Vision Center
Irvine, California, 92604
Tauber Eye Center
Kansas City, Missouri, 64111
Scripps Clinic
La Jolla, California, 92037
University of Arkansas for Medical
Little Rock, Arkansas, 72205
Taustine Eye Center
Louisville, Kentucky, 40217
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345
John-Kenyon American Eye Institute
New Albany, Indiana, 47150
Eye Research Foundation
Newport Beach, California, 92663
Virginia Eye Consultants
Norfolk, Virginia, 23502
Durrie Vision
Overland Park, Kansas, 66061
North Bay Eye Associates, Inc.
Petaluma, California, 94954
Cornea Consultants of Arizona
Phoenix, Arizona, 85032
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Ophthalmic Consultants Long Island
Rockville Centre, New York, 11570
Focus Clinical Research
Salt Lake City, Utah, 84107
Stacy Smith, MD, PC
Salt Lake City, Utah, 84117
Northern New Jersey Eye Institute, PA
South Orange, New Jersey, 07079
Ophthalmology Associates
St Louis, Missouri, 63131
South Shore Eye Care, LLP
Wantagh, New York, 11793
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- AGN-195263 0.1%, AGN-195263 0.03%, AGN-195263 0.01%, AGN-195263 Vehicle
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-195263 0.1%Drug
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
AGN-195263 0.03%Drug
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
AGN-195263 0.01%Drug
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
AGN-195263 VehicleDrug
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
| Study group | Role | What they receive |
|---|---|---|
| AGN-195263 0.1% | Experimental | 1 drop of AGN-195263 0.1% instilled in each eye twice daily. Receives: Drug: AGN-195263 0.1% |
| AGN-195263 0.03% | Experimental | 1 drop of AGN-195263 0.03% instilled in each eye twice daily. Receives: Drug: AGN-195263 0.03% |
| AGN-195263 0.01% | Experimental | 1 drop of AGN-195263 0.01% instilled in each eye twice daily. Receives: Drug: AGN-195263 0.01% |
| AGN-195263 Vehicle | Placebo comparator | 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. Receives: Drug: AGN-195263 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Meibum Quality Responders in the Study Eye
Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
Measured: Month 6
Secondary outcomes (2)
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
The MQS is assessed based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.
Measured: Month 6
Percentage of Complete Overall Ocular Discomfort Responders
Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study start22 Aug 2012
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
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.
- Other trials for Meibomian Gland DysfunctionStudies 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, Care provider, Investigator
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633788
- Sponsor's protocol ID
- 195263-006
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2012
- Last updated
- 8 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT01633788
- Acronym / sponsor ID
- 195263-006
- Conditions
- Meibomian Gland Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2012 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Posted 8 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN-195263 0.1% | Experimental | Drug: AGN-195263 0.1%1 drop of AGN-195263 0.1% instilled in each eye twice daily. |
| AGN-195263 0.03% | Experimental | Drug: AGN-195263 0.03%1 drop of AGN-195263 0.03% instilled in each eye twice daily. |
| AGN-195263 0.01% | Experimental | Drug: AGN-195263 0.01%1 drop of AGN-195263 0.01% instilled in each eye twice daily. |
| AGN-195263 Vehicle | Placebo comparator | Drug: AGN-195263 Vehicle1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meibomian gland dysfunction in both eyes
- Best-corrected visual acuity of 20/40 or better in each eye
Key exclusion criteria (6 listed)
- Known or suspected prostate cancer
- History of breast cancer
- Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
- Contact lens wear in either eye during any portion of the study
- Unable to instill eye drops correctly
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 |
|---|---|---|
| AGN-195263 0.1%1 drop of AGN-195263 0.1% instilled in each eye twice daily. | Drug | AGN-195263 0.1% |
| AGN-195263 0.03%1 drop of AGN-195263 0.03% instilled in each eye twice daily. | Drug | AGN-195263 0.03% |
| AGN-195263 0.01%1 drop of AGN-195263 0.01% instilled in each eye twice daily. | Drug | AGN-195263 0.01% |
| AGN-195263 Vehicle1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. | Drug | AGN-195263 Vehicle |
Primary outcome
Percentage of Meibum Quality Responders in the Study Eye
Time frame: Month 6
Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
2 secondary outcomes
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
Time frame: Month 6
Percentage of Complete Overall Ocular Discomfort Responders
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Medical Director study director
Allergan
33 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 AGN-195263 0.1%, AGN-195263 0.03% and AGN-195263 0.01% in people with Meibomian Gland Dysfunction, run by Allergan at 33 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 2 inclusion and 6 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 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
Yes. Results are posted in the registry (first posted 8 Sep 2017). 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?
Percentage of Meibum Quality Responders in the Study Eye (time frame: Month 6). 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 8 Sep 2017.