A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia

• Sponsor: Encore Vision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02516306
• Collaborator: (none)
• Enrollment: 75
• Locations: 4
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site: 18.8
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and effective in improving distance corrected near vision in people who have presbyopia.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: EV06 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution	Phase 1/Phase 2

Detailed Description

Study subjects who were eligible for enrollment and had provided written informed consent were randomized in a 2:1 ratio to use of either EV06 Ophthalmic Solution or Placebo Ophthalmic Solution. For the first 7 days of study product administration (Period 1: Days 1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. For the next 84 days (Period 2: Days 8 - 91), if there were no unanticipated and no significant adverse events observed in the treated eye, subjects applied 1 drop of their assigned study product to both eyes twice per day.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Prospective, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution, in Improving Distance Corrected Near Vision in Subjects With Presbyopia
• Actual Study Start Date: Sep 16, 2015
• Actual Primary Completion Date: Mar 10, 2016
• Actual Study Completion Date: Mar 10, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EV06 Ophthalmic Solution EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.	Drug: EV06 Ophthalmic Solution; Other Names: Active treatment
Placebo Comparator: Placebo Ophthalmic Solution Placebo Ophthalmic Solution (EV06 vehicle): Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.	Drug: Placebo Ophthalmic Solution; Other Names: Inactive control (vehicle)

Outcome Measures

Primary Outcome Measures

1. Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit [Baseline, Day 7, Day 14, Day 30, Day 60, Day 90]

   Ocular comfort was assessed at Baseline (Day 1) and following the last dose on the day prior to each office visit. Comfort was assessed by each subject marking a visual analog scale labeled "0" (Very Comfortable), "5" (Comfortable) and "10" (Very Uncomfortable) immediately following instillation of their assigned study product to one eye (Baseline) or both eyes (Days 8 - 91). A small number indicated better comfort. No formal inferential statistics hypotheses were tested.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 45 to 55 years of age

• Distance Corrected Near Visual Acuity worse than 20/40

• Best Corrected Distance Visual Acuity of 20/20 or better in each eye

• Willing and able to sign consent, following study instructions

Exclusion Criteria:

• Certain pupillary conditions

• Significant astigmatism, glaucoma, diabetes, cataracts, eye surgery, ocular trauma or accommodative issues

• contact lens wear within 3 days prior to and for duration of study

• use of prohibited medications

• participation in a clinical study within 30 days prior

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Research Medical Center, Inc.	Artesia	California	United States	90701
2	North Valley Eye Medical Group	Mission Hills	California	United States	91345
3	Comprehensive Eye Care, Ltd.	Washington	Missouri	United States	63090
4	Total Eye Care	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Encore Vision, Inc.

Investigators

• Study Director: Expert Clinical Project Lead Ophthalmology, Encore Vision, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Encore Vision, Inc.
• ClinicalTrials.gov Identifier: NCT02516306
• Other Study ID Numbers: EV-C-002
• First Posted: Aug 5, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Oct 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Encore Vision, Inc.: Presbyopia; Vision; UNR844
• Additional relevant MeSH terms: Presbyopia; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	EVO6 Ophthalmic Solution	Placebo
Arm/Group Description	EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.	Placebo Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye. Day 8 - 91 one drop administered twice per day in both eyes.
Period Title: Period 1: Day 1 - 7
STARTED	50	25
COMPLETED	50	25
NOT COMPLETED	0	0
Period Title: Period 1: Day 1 - 7
STARTED	50	25
COMPLETED	49	23
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	EV06 Ophthalmic Solution	Placebo	Total
Arm/Group Description	EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.	Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.	Total of all reporting groups
Overall Participants	50	25	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (3.2)	51.4 (3.0)	50.5 (3.1)
Sex: Female, Male (Count of Participants)
Female	33 66%	20 80%	53 70.7%
Male	17 34%	5 20%	22 29.3%
Region of Enrollment (participants) [Number]
United States	50 100%	25 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit
Description	Ocular comfort was assessed at Baseline (Day 1) and following the last dose on the day prior to each office visit. Comfort was assessed by each subject marking a visual analog scale labeled "0" (Very Comfortable), "5" (Comfortable) and "10" (Very Uncomfortable) immediately following instillation of their assigned study product to one eye (Baseline) or both eyes (Days 8 - 91). A small number indicated better comfort. No formal inferential statistics hypotheses were tested.
Time Frame	Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

Outcome Measure Data

Analysis Population Description

Includes all subjects who completed the study: EV06 Ophthalmic Solution (49 of 50) and Placebo Ophthalmic Solution (23 of 25)

Arm/Group Title	EVO6 Ophthalmic Solution	Placebo Ophthalmic Solution
Arm/Group Description	EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.	Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
Measure Participants	49	23
Day 1	3.2 (2.4)	3.3 (2.5)
Day 7	2.4 (2.4)	2.2 (2.2)
Day 14	2.2 (2.2)	2.3 (2.2)
Day 30	2.4 (2.0)	2.2 (2.2)
Day 60	2.1 (2.1)	3.0 (2.5)
Day 90	2.1 (2.4)	2.1 (2.2)

Adverse Events

Time Frame	Adverse events were collected during the entire duration of the study: Day 1 through 91.
Arm/Group Title	EVO6		Placebo
Arm/Group Description	EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.		Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
All Cause Mortality
	EVO6		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)
Serious Adverse Events
	EVO6		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	EVO6		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/50 (36%)		6/25 (24%)
Eye disorders
Conjunctival hyperaemia	0/50 (0%)	0	2/25 (8%)	2
Eye irritation	3/50 (6%)	3	0/25 (0%)	0
General disorders
Instillation site pain	3/50 (6%)	3	1/25 (4%)	1
Infections and infestations
Nasopharyngitis	8/50 (16%)	8	2/25 (8%)	2
Upper respiratory tract infection	1/50 (2%)	1	2/25 (8%)	2
Nervous system disorders
Disgeusia	7/50 (14%)	7	0/25 (0%)	0
Headache	4/50 (8%)	4	0/25 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.