Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

• Sponsor: Aerie Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03808688
• Collaborator: (none)
• Enrollment: 261
• Locations: 22
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site: 11.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: Netarsudil Ophthalmic Solution 0.02%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 261 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label Study of Rhopressa® (Netarsudil Ophthalmic Solution) 0.02% for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
• Actual Study Start Date: Dec 27, 2018
• Actual Primary Completion Date: Jul 26, 2019
• Actual Study Completion Date: Jul 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Netarsudil Ophthalmic Solution 0.02%	Drug: Netarsudil Ophthalmic Solution 0.02%; 1 drop in each eye once daily in the evening; Other Names: Rhopressa

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) [12 weeks]

   Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

1. Male or female subjects (aged 18 or older)

2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%.

3. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

Key Exclusion Criteria:

1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation

2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study.

3. Known sensitivity or allergy to the study medication or components

4. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results

5. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlantis Eyecare	Huntington Beach	California	United States	92647
2	Harvard Eye Associates	Laguna Hills	California	United States	92653
3	North Bay Eye Associates, Inc	Petaluma	California	United States	94954
4	Shettle Eye Research Inc	Largo	Florida	United States	33773
5	Center For Sight	Sarasota	Florida	United States	34238
6	Coastal Research Associates, LLC	Roswell	Georgia	United States	30076
7	Wheaton Eye Clinic, Ltd	Wheaton	Illinois	United States	60187
8	Stiles Eyecare Excellence and Glaucoma Institute, PA	Overland Park	Kansas	United States	66213
9	Gaddie Eye Centers, LLC	Louisville	Kentucky	United States	40241
10	Glaucoma Consultants	Baltimore	Maryland	United States	21204
11	Tekwani Vision Center	Saint Louis	Missouri	United States	63128
12	Mark J. Weiss, M.D., Inc.	Tulsa	Oklahoma	United States	74104
13	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania	United States	16066
14	Valley Eye Professionals, LLC	Huntingdon Valley	Pennsylvania	United States	19006
15	Carolina Cataract & Laser Center	Ladson	South Carolina	United States	29456
16	Total Eye Care, PA	Memphis	Tennessee	United States	38119
17	VRF Eye Specialty Group	Memphis	Tennessee	United States	38120
18	Advancing Vision Research	Nashville	Tennessee	United States	37204
19	Keystone Research	Austin	Texas	United States	78731
20	Cataract & Glaucoma Center	El Paso	Texas	United States	79902
21	Houston Eye Associates	Houston	Texas	United States	77025
22	The Eye Centers of Racine and Kenosha	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

• Aerie Pharmaceuticals

Investigators

• Study Director: David Hollander, MD, MBA, Aerie Pharmaceuticals, Inc.

Study Documents (Full-Text)

• Study Protocol - Dec 18, 2018
• Statistical Analysis Plan - Aug 15, 2019

More Information

Publications

None provided.

• Responsible Party: Aerie Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03808688
• Other Study ID Numbers: MA-RHO-18-002
• First Posted: Jan 17, 2019
• Last Update Posted: Sep 29, 2020
• Last Verified: Nov 1, 2019

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

Study Results

Participant Flow

Recruitment Details	A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.
Pre-assignment Detail	The enrolled population includes all subjects who signed ICF. One subject enrolled but withdrew consent before study drug dispensed; thus, post-baseline treatment is unavailable. Participant Flow data represents ITT population. Clarification of enrolled (n= 261) vs treated (n=260) subjects is provided in Recruitment & Pre-assignment sections.

Arm/Group Title	Netarsudil Ophthalmic Solution 0.02% Monotherapy	Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
Arm/Group Description	Netarsudil Ophthalmic Solution 0.02% Monotherapy: 1 drop in each eye once daily in the evening.	Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
Period Title: Overall Study
STARTED	99	161
COMPLETED	81	138
NOT COMPLETED	18	23

Baseline Characteristics

Arm/Group Title	Netarsudil Ophthalmic Solution 0.02% Monotherapy	Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy	Total
Arm/Group Description	Netarsudil Ophthalmic Solution 0.02% Monotherapy - 1 drop in each eye once daily in the evening.	Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.	Total of all reporting groups
Overall Participants	91	151	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.2 (11.85)	67.2 (10.53)	67.2 (11.02)
Sex: Female, Male (Count of Participants)
Female	57 62.6%	91 60.3%	148 61.2%
Male	34 37.4%	60 39.7%	94 38.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 12.1%	8 5.3%	19 7.9%
Not Hispanic or Latino	80 87.9%	143 94.7%	223 92.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.1%	0 0%	1 0.4%
Asian	0 0%	3 2%	3 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 14.3%	45 29.8%	58 24%
White	77 84.6%	102 67.5%	179 74%
More than one race	0 0%	1 0.7%	1 0.4%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP)
Description	Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.

Arm/Group Title	Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline	Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent	Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents	Netarsudil Ophth Sol 0.02% Concomitant Therapy
Arm/Group Description	During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Treatment naïve at baseline visit. 1 drop in each eye once daily in the evening.	During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 1 agent at baseline visit (majority were PGA replacements). 1 drop in each eye once daily in the evening.	During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 2 agents at baseline visit (including PGA and FDC replacements). 1 drop in each eye once daily in the evening.	During study Netarsudil Ophthalmic Solution 0.02% - Used concomitantly with other IOP lowering agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
Measure Participants	24	61	6	151
Mean (Standard Deviation) [percent change]	-16.9 (16.35)	-2.3 (16.23)	0.2 (8.81)	-17.0 (16.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline, Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent, Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents, Netarsudil Ophth Sol 0.02% Concomitant Therapy
	Comments	Cohorts assessed versus baseline treatment
	Type of Statistical Test	Other
	Comments	Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.

Adverse Events

Time Frame	Adverse event data was collected during the course of the 12-week treatment period.
Adverse Event Reporting Description	The safety population included all subjects who received at least 1 dose of study medication.
Arm/Group Title	Netarsudil Ophthalmic Solution 0.02% Monotherapy		Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
Arm/Group Description	Netarsudil Ophthalmic Solution 0.02% Monotherapy. 1 drop in each eye once daily in the evening.		Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
All Cause Mortality
	Netarsudil Ophthalmic Solution 0.02% Monotherapy		Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/161 (0%)
Serious Adverse Events
	Netarsudil Ophthalmic Solution 0.02% Monotherapy		Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/99 (2%)		1/161 (0.6%)
Infections and infestations
Cellulitis Lower Left Extremity	0/99 (0%)	0	1/161 (0.6%)	1
Pneumonia	1/99 (1%)	1	0/161 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma of Eyelid	1/99 (1%)	1	0/161 (0%)	0
Other (Not Including Serious) Adverse Events
	Netarsudil Ophthalmic Solution 0.02% Monotherapy		Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/99 (43.4%)		58/161 (36%)
Eye disorders
Conjunctival Hyperemia	22/99 (22.2%)	22	32/161 (19.9%)	32
Vision Blurred	9/99 (9.1%)	9	10/161 (6.2%)	10
Conjunctival Hemorrage	6/99 (6.1%)	6	8/161 (5%)	8
Instillation Site Pain	6/99 (6.1%)	6	8/161 (5%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.