Healthy VolunteersPhase 1NCT02420730
Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
A Phase 1 study testing AGN-232411 in people with Healthy Volunteers and Dry Eye Syndromes, run by Allergan at 3 sites in United States.
Trial summary
This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Dry Eye Syndromes
- What is being tested?
- AGN-232411
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage 1
- -Healthy participants.
- Stage 2 -Participants with the symptoms of dry eye disease.
Who cannot join
- Stage 1
- -Known allergies or sensitivities to study medications, fluorescein, or lissamine green
- Stage 2
- Known allergies or sensitivities to study medications, fluorescein, or lissamine green
- Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months
- History of any ocular surgery within the previous 12 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sall Research Center
Artesia, California, 90701
Lugene Eye Institute
Glendale, California, 91204
Montebello Medical Center, Inc.
Montebello, California, 90640
About this study
This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.
- Conditions
- Healthy Volunteers, Dry Eye Syndromes
- Being tested
- AGN-232411, AGN-232411 Vehicle
- 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-232411Drug
AGN-232411 topical ophthalmic solution
AGN-232411 VehicleDrug
Vehicle for AGN-232411 topical ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A: AGN-232411 Dose A | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. Receives: Drug: AGN-232411 |
| Cohort 1B: AGN-232411 Dose B | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable. Receives: Drug: AGN-232411 |
| Cohort 1C: AGN-232411 Dose C | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable. Receives: Drug: AGN-232411 |
| Cohort 1: AGN-232411 Vehicle | Placebo comparator | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. Receives: Drug: AGN-232411 Vehicle |
| Cohort 2A: AGN-232411 Dose A | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. Receives: Drug: AGN-232411 |
| Cohort 2B: AGN-232411 Dose B | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable. Receives: Drug: AGN-232411 |
| Cohort 2C: AGN-232411 Dose C | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable. Receives: Drug: AGN-232411 |
| Cohort 2: AGN-232411 Vehicle | Placebo comparator | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. Receives: Drug: AGN-232411 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 77 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
- NCT02420730
- Sponsor's protocol ID
- 232411-001
- Status last verified
- Jul 2016
- First submitted
- 15 Apr 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
- ClinicalTrials.gov ID
- NCT02420730
- Acronym / sponsor ID
- 232411-001
- Conditions
- Healthy Volunteers, Dry Eye Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Apr 2015 (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 study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A: AGN-232411 Dose A | Experimental | Drug: AGN-232411One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
| Cohort 1B: AGN-232411 Dose B | Experimental | Drug: AGN-232411One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable. |
| Cohort 1C: AGN-232411 Dose C | Experimental | Drug: AGN-232411One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable. |
| Cohort 1: AGN-232411 Vehicle | Placebo comparator | Drug: AGN-232411 VehicleOne drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
| Cohort 2A: AGN-232411 Dose A | Experimental | Drug: AGN-232411One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
| Cohort 2B: AGN-232411 Dose B | Experimental | Drug: AGN-232411One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable. |
| Cohort 2C: AGN-232411 Dose C | Experimental | Drug: AGN-232411One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable. |
| Cohort 2: AGN-232411 Vehicle | Placebo comparator | Drug: AGN-232411 VehicleOne drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage 1
- -Healthy participants.
- Stage 2 -Participants with the symptoms of dry eye disease.
Key exclusion criteria (6 listed)
- Stage 1
- -Known allergies or sensitivities to study medications, fluorescein, or lissamine green
- Stage 2
- Known allergies or sensitivities to study medications, fluorescein, or lissamine green
- Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 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 |
|---|---|---|
| AGN-232411AGN-232411 topical ophthalmic solution | Drug | Cohort 1A: AGN-232411 Dose A, Cohort 1B: AGN-232411 Dose B, Cohort 1C: AGN-232411 Dose C, Cohort 2A: AGN-232411 Dose A, Cohort 2B: AGN-232411 Dose B, Cohort 2C: AGN-232411 Dose C |
| AGN-232411 VehicleVehicle for AGN-232411 topical ophthalmic solution. | Drug | Cohort 1: AGN-232411 Vehicle, Cohort 2: AGN-232411 Vehicle |
Primary outcome
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 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 14 Jul 2016.
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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
3 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 AGN-232411 in people with Healthy Volunteers and Dry Eye Syndromes, run by Allergan at 3 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 3 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 56 days). 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 14 Jul 2016.