A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:

An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285580
• Other study ID #: 1698-304-007
• Status: Completed
• Phase: Phase 3
• Start date: June 11, 2020
• Est. completion date: May 14, 2022

Study information

• Verified date: May 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 14, 2022
• Est. primary completion date: May 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment

• Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months

Exclusion Criteria:

• Current or anticipated enrollment in another investigational drug or device study

• Females who are pregnant, nursing, or planning a pregnancy during the study

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Bimatoprost SR
Consists of 1 Bimatoprost SR administration in the study eye.
• LUMIGAN
Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.

Locations

Country	Name	City	State
United States	Keystone Research LTD /ID# 232665	Austin	Texas
United States	Scott and Christie and Associates /ID# 232747	Cranberry Township	Pennsylvania
United States	Trinity Research Group /ID# 232749	Dothan	Alabama
United States	The Eye Research Foundation /ID# 232694	Newport Beach	California
United States	Coastal Research Associates /ID# 232798	Roswell	Georgia
United States	James D Branch MD /ID# 232718	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes	IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.	8 weeks
Primary	Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)	The number of patients who experienced one or more TEAEs	Up to 12 Months
Secondary	Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes	IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP.	8 Weeks