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

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04285580
• Collaborator: (none)
• Enrollment: 38
• Locations: 6
• Arms: 2
• Actual Duration (Months): 23.1
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	Drug: Bimatoprost SR; Drug: LUMIGAN	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jun 11, 2020
• Actual Primary Completion Date: May 14, 2022
• Actual Study Completion Date: May 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimatoprost SR 10 μg Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.	Drug: Bimatoprost SR; Consists of 1 Bimatoprost SR administration in the study eye.
Other: LUMIGAN 0.01% Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR treated eyes [8 weeks]

   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.

2. Number of patients experiencing one or more treatment emergent adverse events (TEAEs) [Up to 12 months]

   The number of patients who experienced one or more TEAEs

Secondary Outcome Measures

1. Change from Baseline in range of IOP for Bimatoprost SR-treated eyes [8 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Research Group /ID# 232749	Dothan	Alabama	United States	36301
2	The Eye Research Foundation /ID# 232694	Newport Beach	California	United States	92663-3637
3	Coastal Research Associates /ID# 232798	Roswell	Georgia	United States	30076
4	James D Branch MD /ID# 232718	Winston-Salem	North Carolina	United States	27101
5	Scott and Christie and Associates /ID# 232747	Cranberry Township	Pennsylvania	United States	16066
6	Keystone Research LTD /ID# 232665	Austin	Texas	United States	78731-4203

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.
• To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT04285580
• Other Study ID Numbers: 1698-304-007
• First Posted: Feb 26, 2020
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Bimatoprost

Study Results

No Results Posted as of May 18, 2022