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

NCT01959230 | Completed Phase 3 Results

• 1 other identifier: 861
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemia

Keywords

Ocular redness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Ocular Redness as Measured by the Participant

  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

  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

Study Arms (2)

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.

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.

Drug: Vehicle; Drug: Sodium Fluorescein; Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

Interventions

Brimonidine Tartrate DRUG

Ophthalmic solution to be applied as directed.

Brimonidine Tartrate

Vehicle DRUG

Ophthalmic solution to be applied as directed.

Brimonidine Tartrate Vehicle

Sodium Fluorescein DRUG

For use as needed during the study for evaluating corneal damage.

Brimonidine Tartrate; Brimonidine Tartrate Vehicle

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP DRUG

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Brimonidine Tartrate; Brimonidine Tartrate Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead
• ORA, Inc.: collaborator

Study Sites (1)

Bausch & Lomb Incorporated

Memphis, Tennessee, 38119, United States

Location

Related Publications (1)

• 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.

  PMID: 29461408 DERIVED

MeSH Terms

Conditions

Hyperemia

Interventions

Brimonidine Tartrate; Fluorescein

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Polycyclic Compounds

Results Point of Contact

• Title: Director, Medical Affairs
• Organization: Bausch & Lomb Incorporated

Heleen.DeCory@bausch.com

Study Officials

• Heleen DeCory

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 9, 2013
• Study Start: November 7, 2013
• Primary Completion: December 20, 2013
• Study Completion: December 20, 2013
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Locations

US (1)