HyperemiaPhase 3NCT01959230
Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
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 1 site in United States.
Trial summary
To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2013to 20 Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Have a history of redness relief drops use or expressed a desire to use drops for redness relief, within the last 6 months.
- Have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Who cannot join
- Any ocular/systemic health problems.
- Use of any disallowed medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Memphis, Tennessee, 38119
About this study
Official title: A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness
To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.
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.
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.
Measured: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1
Secondary outcomes (2)
Ocular Redness as Measured by the Participant
Ocular redness was scored daily pre-dose and post-dose on Days 1 to 29 and scored daily on Days 30 to 36 by the participant using a 0 to 4 unit scale (not allowing half unit increments). A lower score was indicative of less redness. The LOCF method used for this Secondary Outcome Measure was for imputing missing daily post-dose mean scores for entire days. If ≥1 score was provided for a day, imputation was not done. Imputation was done within the dosing period and separately within the follow-up period. The average (mean) daily pre-dose and post-dose scores for the dosing period Day 1 to Day 15 and dosing period Day 15 to Day 29, and the average (mean) daily score for the follow-up period Day 29 to Day 36 are reported.
Measured: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale
Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.
Measured: 0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 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 start7 Nov 2013
- Primary completion20 Dec 2013
- Study completion20 Dec 2013
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 (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT01959230
- Sponsor's protocol ID
- 861
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2013
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McLaurin E, Cavet ME, Gomes PJ, Ciolino JB. Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optom Vis Sci. 2018 Mar;95(3):264-271. doi: 10.1097/OPX.0000000000001182.
PubMed 29461408
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 Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness
- ClinicalTrials.gov ID
- NCT01959230
- Acronym / sponsor ID
- 861
- Conditions
- Hyperemia
- Keywords
- Ocular redness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 7 Nov 2013 (actual)
- Primary completion
- 20 Dec 2013 (actual)
- Study completion
- 20 Dec 2013 (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 efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.
Study design
- Primary purpose
- Treatment
- 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Have a history of redness relief drops use or expressed a desire to use drops for redness relief, within the last 6 months.
- Have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Key exclusion criteria (2 listed)
- Any ocular/systemic health problems.
- Use of any disallowed medications.
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
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
Time frame: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1
Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.
2 secondary outcomes
Ocular Redness as Measured by the Participant
Time frame: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36
Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale
Time frame: 0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 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.
- Derived from this study: PubMed 29461408McLaurin E, Cavet ME, Gomes PJ, Ciolino JB. Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optom Vis Sci. 2018 Mar;95(3):264-271. doi: 10.1097/OPX.0000000000001182.
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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
1 site 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 1 site 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 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 1 site 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?
Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale (time frame: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1). 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 NCT01959230, which also lists 1 linked publication.
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.