HyperemiaPhase 3NCT01959243
Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants
A Phase 3 study testing Brimonidine Tartrate, Sodium Fluorescein and Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP in people with Hyperemia, run by Bausch & Lomb Incorporated at 4 sites in United States.
Trial summary
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperemia
- What is being tested?
- Brimonidine Tartrate, Sodium Fluorescein and Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 507 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Feb 2014to 23 Jun 2014
- Phase
- Phase 3
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
- Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
Who cannot join
- Have any ocular/systemic health problems
- Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bausch Site 1
Andover, Massachusetts, 01810
Bausch Site 4
Havre de Grace, Maryland, 21078
Bausch Site 2
Philadelphia, Pennsylvania, 19148
Bausch Site 3
Phoenix, Arizona, 85032
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine TartrateDrug
Ophthalmic solution to be applied as directed.
VehicleDrug
Ophthalmic solution to be applied as directed.
Sodium FluoresceinDrug
For use as needed during the study for evaluating corneal damage.
Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USPDrug
For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine Tartrate | Experimental | Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. Receives: Drug: Brimonidine Tartrate; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP |
| Brimonidine Tartrate Vehicle | Placebo comparator | Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. Receives: Drug: Vehicle; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to Day 29
Secondary outcomes (2)
Drop Comfort Assessment as Assessed by the Participant
Drop comfort assessment (0-10 unit scale in which a score of 0 denotes "very comfortable" and 10 is "very uncomfortable") was performed by the participant. Participant's average score across eyes at each time point were used for analysis.
Measured: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma.
Measured: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study start22 Feb 2014
- Primary completion23 Apr 2014
- Study completion23 Jun 2014
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 HyperemiaStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Heleen DeCory, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959243
- Sponsor's protocol ID
- 862
- Status last verified
- Sep 2019
- First submitted
- 8 Oct 2013
- Last updated
- 23 Oct 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects
- ClinicalTrials.gov ID
- NCT01959243
- Acronym / sponsor ID
- 862
- Conditions
- Hyperemia
- Keywords
- Ocular redness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 22 Feb 2014 (actual)
- Primary completion
- 23 Apr 2014 (actual)
- Study completion
- 23 Jun 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brimonidine Tartrate | Experimental | Drug: Brimonidine Tartrate, Drug: Sodium Fluorescein, Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USPParticipants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. |
| Brimonidine Tartrate Vehicle | Placebo comparator | Drug: Vehicle, Drug: Sodium Fluorescein, Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USPParticipants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
- Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
Key exclusion criteria (2 listed)
- Have any ocular/systemic health problems
- Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.
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 TartrateOphthalmic solution to be applied as directed. | Drug | Brimonidine Tartrate |
| VehicleOphthalmic solution to be applied as directed. | Drug | Brimonidine Tartrate Vehicle |
| Sodium FluoresceinFor use as needed during the study for evaluating corneal damage. | Drug | Brimonidine Tartrate, Brimonidine Tartrate Vehicle |
| Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USPFor use as needed during the study for intraocular pressure and dilated ophthalmoscopy. | Drug | Brimonidine Tartrate, Brimonidine Tartrate Vehicle |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 29
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.
2 secondary outcomes
Drop Comfort Assessment as Assessed by the Participant
Time frame: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
Time frame: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
Heleen DeCory study director
Bausch & Lomb Incorporated
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brimonidine Tartrate, Sodium Fluorescein and Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP in people with Hyperemia, run by Bausch & Lomb Incorporated at 4 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 2 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Oct 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 29). 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 23 Oct 2019.