Dry Eye SyndromesPhase 2NCT02435914
Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
A Phase 2 study testing AGN-223575 ophthalmic solution in people with Dry Eye Syndromes, run by Allergan at 28 sites in United States.
Trial summary
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- AGN-223575 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 28 sitesUnited States
- Study dates
- Jun 2015to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs and symptoms of dry eye disease
- Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
Who cannot join
- History of glaucoma, or ocular hypertension
- Diagnosis of ocular infection
- Use of contact lenses in the past 14 days or expected use during the study
- Use of any topical ophthalmic medications in the past 30 days
- Use of corticosteroids in the past 30 days.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Keystone Clinical Research
Austin, Texas, 78731
Tufts Medical Center/ Tufts University School of Medicine
Boston, Massachusetts, 02111
Bluestein Custom Vision
Charleston, South Carolina, 29414
SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
Charlotte, North Carolina, 28210
Eye Care Associates of Greater Cincinnati
Cincinnati, Ohio, 45236
Eye Associates of Colorado Springs
Colorado Springs, Colorado, 80909
Carolinas Centers for Sight, PC
Florence, South Carolina, 29501
Specialty Eye Ctr. Med. Group
Glendale, California, 91203
Cornerstone Eye Care
High Point, North Carolina, 27262
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
Houston Eye Associates
Houston, Texas, 77025
Whitsett Vision Group
Houston, Texas, 77055
Moyes Eye Center
Kansas City, Missouri, 64154
West Coast Eye Institute
Lecanto, Florida, 34491
Kentucky Center for Vision
Lexington, Kentucky, 40509
Eye Care Centers Management, Inc.
Morrow, Georgia, 30260
Raymond Fong MD, PC
New York, New York, 10013
The Eye Research Foundation
Newport Beach, California, 92663
Durrie Vision
Overland Park, Kansas, 66211
Arizona Center for Clinical Trials
Phoenix, Arizona, 85003
Mark A. Terry, MD PC/ Devers Eye Institute
Portland, Oregon, 97210
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Coastal Research Assoc. LLC
Roswell, Georgia, 30076
Medical Center Opth. Assoc.
San Antonio, Texas, 78240
WCCT Global
Santa Ana, California, 92705
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, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- AGN-223575 ophthalmic solution, AGN-223575 vehicle ophthalmic solution
- 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.
AGN-223575 ophthalmic solutionDrug
AGN-223575 ophthalmic solution once or twice daily
AGN-223575 vehicle ophthalmic solutionDrug
Vehicle to AGN22375 ophthalmic solution once or twice daily.
| Study group | Role | What they receive |
|---|---|---|
| AGN-223575 Dose A | Experimental | 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. Receives: Drug: AGN-223575 ophthalmic solution; Drug: AGN-223575 vehicle ophthalmic solution |
| AGN-223575 Dose B | Experimental | 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. Receives: Drug: AGN-223575 ophthalmic solution; Drug: AGN-223575 vehicle ophthalmic solution |
| AGN-223575 Dose C | Experimental | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. Receives: Drug: AGN-223575 ophthalmic solution; Drug: AGN-223575 vehicle ophthalmic solution |
| AGN-223575 Vehicle | Placebo comparator | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. Receives: Drug: AGN-223575 vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.
Measured: Baseline, Day 14
Secondary outcomes (3)
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 14
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 14
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness).
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Dry Eye SyndromesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 236 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
- NCT02435914
- Sponsor's protocol ID
- 223575-002
- Status last verified
- Mar 2019
- First submitted
- 1 May 2015
- Last updated
- 5 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02435914
- Acronym / sponsor ID
- 223575-002
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 5 Apr 2019
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, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN-223575 Dose A | Experimental | Drug: AGN-223575 ophthalmic solution, Drug: AGN-223575 vehicle ophthalmic solution1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| AGN-223575 Dose B | Experimental | Drug: AGN-223575 ophthalmic solution, Drug: AGN-223575 vehicle ophthalmic solution1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| AGN-223575 Dose C | Experimental | Drug: AGN-223575 ophthalmic solution, Drug: AGN-223575 vehicle ophthalmic solution1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| AGN-223575 Vehicle | Placebo comparator | Drug: AGN-223575 vehicle ophthalmic solution1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signs and symptoms of dry eye disease
- Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
Key exclusion criteria (5 listed)
- History of glaucoma, or ocular hypertension
- Diagnosis of ocular infection
- Use of contact lenses in the past 14 days or expected use during the study
- Use of any topical ophthalmic medications in the past 30 days
- Use of corticosteroids in the past 30 days.
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-223575 ophthalmic solutionAGN-223575 ophthalmic solution once or twice daily | Drug | AGN-223575 Dose A, AGN-223575 Dose B, AGN-223575 Dose C |
| AGN-223575 vehicle ophthalmic solutionVehicle to AGN22375 ophthalmic solution once or twice daily. | Drug | AGN-223575 Dose A, AGN-223575 Dose B, AGN-223575 Dose C, AGN-223575 Vehicle |
Primary outcome
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
Time frame: Baseline, Day 14
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.
3 secondary outcomes
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
Time frame: Baseline, Day 14
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
Time frame: Baseline, Day 14
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
28 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-223575 ophthalmic solution in people with Dry Eye Syndromes, run by Allergan at 28 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 5 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 5 Apr 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?
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale (time frame: Baseline, Day 14). 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 5 Apr 2019.