Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

• Sponsor: Ocular Therapeutix, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02914509
• Collaborator: (none)
• Enrollment: 565
• Locations: 10
• Arms: 2
• Actual Duration (Months): 28.7
• Patients Per Site: 56.5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma; Ocular Hypertension	Drug: Travoprost; Other: Placebo Vehicle	Phase 3

Detailed Description

This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.

Study Design

• Study Type: Interventional
• Actual Enrollment: 565 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension
• Actual Study Start Date: Nov 7, 2016
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTX-TP (sustained release travoprost) Intracanalicular Depot OTX-TP (sustained release travoprost) Intracanalicular Depot	Drug: Travoprost
Placebo Comparator: PV (Placebo Vehicle) Intracanalicular Depot PV (Placebo Vehicle) Intracanalicular Depot	Other: Placebo Vehicle

Outcome Measures

Primary Outcome Measures

1. Mean IOP [Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit]

2. Mean IOP [Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit]

3. Mean IOP [Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit]

Other Outcome Measures

1. Number of Participants With Serious Adverse Events [Through study completion, an average of 23 months]

   Number of Participants with Serious Adverse Events

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession

• IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

• Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge

• A history of an inadequate response or no response to topical prostaglandin

• Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States
2		Colorado Springs	Colorado	United States
3		Lakeland	Florida	United States
4		Morrow	Georgia	United States
5		Shawnee Mission	Kansas	United States
6		Des Peres	Missouri	United States
7		Rochester	New York	United States
8		Raleigh	North Carolina	United States
9		Cincinnati	Ohio	United States
10		Austin	Texas	United States

Sponsors and Collaborators

• Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - May 2, 2017
• Statistical Analysis Plan - Jan 2, 2018

More Information

Publications

None provided.

• Responsible Party: Ocular Therapeutix, Inc.
• ClinicalTrials.gov Identifier: NCT02914509
• Other Study ID Numbers: OTX-16-002
• First Posted: Sep 26, 2016
• Last Update Posted: Oct 11, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Travoprost

Study Results

Participant Flow

Arm/Group Title	OTX-TP	Placebo Vehicle (PV)
Arm/Group Description	Three forty eight (348) subjects were randomized to OTX-TP	Two hundred seventeen (217) subjects were randomized to the PV.
Period Title: Overall Study
STARTED	348	217
COMPLETED	343	211
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot	Placebo Vehicle (PV)	Total
Arm/Group Description	Three hundred forty eight (348) subjects were randomized to OTX-TP	Two hundred seventeen (217) subjects were randomized to the PV.	Total of all reporting groups
Overall Participants	348	217	565
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	160 46%	91 41.9%	251 44.4%
>=65 years	188 54%	126 58.1%	314 55.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (11)	65 (11)	65 (11)
Sex: Female, Male (Count of Participants)
Female	185 53.2%	135 62.2%	320 56.6%
Male	163 46.8%	82 37.8%	245 43.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	247 71%	159 73.3%	406 71.9%
African American	84 24.1%	48 22.1%	132 23.4%
Other	17 4.9%	10 4.6%	27 4.8%
Region of Enrollment (participants) [Number]
United States	348 100%	217 100%	565 100%

Outcome Measures

1. Primary Outcome

Title	Mean IOP
Time Frame	Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot	Placebo Vehicle (PV)
Arm/Group Description	Three hundred forty eight (348) subjects were randomized to OTX-TP	Two hundred seventeen (217) subjects were randomized to the PV.
Measure Participants	343	211
8AM	21 (0.2)	22.9 (0.2)
10AM	20.2 (0.2)	21.9 (0.2)
4PM	19.5 (0.2)	21.5 (0.2)

2. Primary Outcome

Title	Mean IOP
Time Frame	Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot	Placebo Vehicle (PV)
Arm/Group Description	Three hundred forty eight (343) subjects were randomized to OTX-TP	Two hundred seventeen (211) subjects were randomized to the PV.
Measure Participants	343	211
8AM	21.9 (0.2)	26.9 (0.3)
10AM	25.1 (0.2)	25 (0.2)
4PM	24.8 (0.2)	24.6 (0.2)

3. Primary Outcome

Title	Mean IOP
Time Frame	Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot	Placebo Vehicle (PV)
Arm/Group Description	Three hundred forty eight (343) subjects were randomized to OTX-TP	Two hundred seventeen (211) subjects were randomized to the PV.
Measure Participants	343	211
8AM	22.8 (0.2)	23.2 (0.3)
10AM	21.7 (0.2)	22.5 (0.2)
4PM	21.4 (0.2)	22.1 (0.2)

4. Other Pre-specified Outcome

Title	Number of Participants With Serious Adverse Events
Description	Number of Participants with Serious Adverse Events
Time Frame	Through study completion, an average of 23 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot	Placebo Vehicle (PV)
Arm/Group Description	Three hundred forty eight (348) subjects were randomized to OTX-TP	Two hundred seventeen (217) subjects were randomized to the PV.
Measure Participants	348	217
Count of Participants [Participants]	7 2%	6 2.8%

Adverse Events

Time Frame	through study duration, an average of 23 months
Arm/Group Title	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot		Placebo Vehicle (PV)
Arm/Group Description	Three hundred forty eight (348) subjects were randomized to OTX-TP		Two hundred seventeen (217) subjects were randomized to the PV.
All Cause Mortality
	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot		Placebo Vehicle (PV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/348 (0.3%)		0/217 (0%)
Serious Adverse Events
	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot		Placebo Vehicle (PV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/348 (2%)		6/217 (2.8%)
Cardiac disorders
Serious Adverse Event	1/348 (0.3%)		1/217 (0.5%)
Ear and labyrinth disorders
Serious Adverse Events	0/348 (0%)		1/217 (0.5%)
Infections and infestations
Serious Adverse Event	1/348 (0.3%)		2/217 (0.9%)
Injury, poisoning and procedural complications
Serious Adverse Event	0/348 (0%)		1/217 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious Adverse Event	1/348 (0.3%)		0/217 (0%)
Nervous system disorders
Serious Adverse Event	2/348 (0.6%)		0/217 (0%)
Respiratory, thoracic and mediastinal disorders
Serious Adverse Event	0/348 (0%)		1/217 (0.5%)
Skin and subcutaneous tissue disorders
Serious Adverse Event	1/348 (0.3%)		0/217 (0%)
Vascular disorders
Serious Adverse Event	1/348 (0.3%)		0/217 (0%)
Other (Not Including Serious) Adverse Events
	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot		Placebo Vehicle (PV)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	132/348 (37.9%)		65/217 (30%)
General disorders
Adverse Event	132/348 (37.9%)		65/217 (30%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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