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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine Tartrate | Drug | Ophthalmic solution to be applied as directed. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heleen DeCory | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Memphis | Tennessee | 38119 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29461408 | Derived | 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. |
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Participants were randomized in a 2:1 ratio to receive brimonidine tartrate ophthalmic solution or the vehicle of brimonidine tartrate ophthalmic solution, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine Tartrate | Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. |
| FG001 | Brimonidine Tartrate Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle |
| Drug |
Ophthalmic solution to be applied as directed. |
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| Sodium Fluorescein | Drug | For use as needed during the study for evaluating corneal damage. |
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| Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP | Drug | For use as needed during the study for intraocular pressure and dilated ophthalmoscopy. |
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| 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. | 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 |
Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants who received at least 1 dose of study drug (Safety Population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Brimonidine Tartrate | Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. |
| BG001 | Brimonidine Tartrate Vehicle | Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (Intent-to-Treat [ITT] Population). Last Observation Carried Forward (LOCF) was used to impute missing data. | Posted | Mean | Standard Deviation | units on a scale | 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1 |
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| Secondary | 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. | All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (ITT Population) with evaluable participant-recorded ocular redness data. LOCF method used as described in the Outcome Measure Description. | Posted | Mean | Standard Deviation | units on a scale | Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36 |
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| Secondary | 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. | All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (ITT Population) with evaluable Investigator-recorded ocular redness data. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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Baseline up to Day 36
All randomized participants who received at least 1 dose of study drug (Safety Population).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brimonidine Tartrate | Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. | 0 | 40 | 10 | 40 | ||
| EG001 | Brimonidine Tartrate Vehicle | Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. | 0 | 20 | 1 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Medical Affairs | Bausch & Lomb Incorporated | Heleen.DeCory@bausch.com |
| ID | Term |
|---|---|
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011083 | Polycyclic Compounds |
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| Male |
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| 15 minutes Postdose |
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| 30 minutes Postdose |
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| 60 minutes Postdose |
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| 90 minutes Postdose |
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| 120 minutes Postdose |
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| 180 minutes Postdose |
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| 240 minutes Postdose |
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Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. |
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