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Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness

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ClinicalTrials.gov Identifier: NCT01959230
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperemia Drug: Brimonidine Tartrate Drug: Vehicle Drug: Sodium Fluorescein Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 7, 2013
Actual Primary Completion Date : December 20, 2013
Actual Study Completion Date : December 20, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brimonidine Tartrate
Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks.
Drug: Brimonidine Tartrate
Ophthalmic solution to be applied as directed.

Drug: Sodium Fluorescein
For use as needed during the study for evaluating corneal damage.

Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Placebo Comparator: Brimonidine Tartrate Vehicle
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.
Drug: Vehicle
Ophthalmic solution to be applied as directed.

Drug: Sodium Fluorescein
For use as needed during the study for evaluating corneal damage.

Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ocular Redness as Measured by the Participant [ Time Frame: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36 ]
    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.

  2. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any ocular/systemic health problems.
  • Use of any disallowed medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959230


Locations
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United States, Tennessee
Bausch & Lomb Incorporated
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Bausch & Lomb Incorporated
ORA, Inc.
Investigators
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Study Director: Heleen DeCory Bausch & Lomb Incorporated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01959230    
Other Study ID Numbers: 861
First Posted: October 9, 2013    Key Record Dates
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by Bausch & Lomb Incorporated:
Ocular redness
Additional relevant MeSH terms:
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Hyperemia
Erythema
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Brimonidine Tartrate
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs