Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia (NCT NCT02516306)

Last Updated: 2018-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

Results posted on

2018-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	EVO6 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.	Placebo 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 1: Day 1 - 7 STARTED	50	25
Period 1: Day 1 - 7 COMPLETED	50	25
Period 1: Day 1 - 7 NOT COMPLETED	0	0
Period 2: Day 8 - 91 STARTED	50	25
Period 2: Day 8 - 91 COMPLETED	49	23
Period 2: Day 8 - 91 NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	EVO6 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.	Placebo 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 2: Day 8 - 91 Protocol Violation	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EV06 Ophthalmic Solution n=50 Participants 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 n=25 Participants 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 n=75 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 3.2 • n=5 Participants	51.4 years STANDARD_DEVIATION 3.0 • n=7 Participants	50.5 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	20 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	5 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	25 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

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

Outcome measures

Outcome measures
Measure	EVO6 Ophthalmic Solution n=49 Participants 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 n=23 Participants 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.
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit Day 1	3.2 units on a scale Standard Deviation 2.4	3.3 units on a scale Standard Deviation 2.5
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit Day 7	2.4 units on a scale Standard Deviation 2.4	2.2 units on a scale Standard Deviation 2.2
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit Day 14	2.2 units on a scale Standard Deviation 2.2	2.3 units on a scale Standard Deviation 2.2
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit Day 30	2.4 units on a scale Standard Deviation 2.0	2.2 units on a scale Standard Deviation 2.2
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit Day 60	2.1 units on a scale Standard Deviation 2.1	3.0 units on a scale Standard Deviation 2.5
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit Day 90	2.1 units on a scale Standard Deviation 2.4	2.1 units on a scale Standard Deviation 2.2

Adverse Events

EVO6

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EVO6 n=50 participants at risk 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 n=25 participants at risk 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.
Eye disorders Conjunctival hyperaemia	0.00% 0/50 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	8.0% 2/25 • Number of events 2 • Adverse events were collected during the entire duration of the study: Day 1 through 91.
Eye disorders Eye irritation	6.0% 3/50 • Number of events 3 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	0.00% 0/25 • Adverse events were collected during the entire duration of the study: Day 1 through 91.
General disorders Instillation site pain	6.0% 3/50 • Number of events 3 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	4.0% 1/25 • Number of events 1 • Adverse events were collected during the entire duration of the study: Day 1 through 91.
Infections and infestations Nasopharyngitis	16.0% 8/50 • Number of events 8 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	8.0% 2/25 • Number of events 2 • Adverse events were collected during the entire duration of the study: Day 1 through 91.
Infections and infestations Upper respiratory tract infection	2.0% 1/50 • Number of events 1 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	8.0% 2/25 • Number of events 2 • Adverse events were collected during the entire duration of the study: Day 1 through 91.
Nervous system disorders Disgeusia	14.0% 7/50 • Number of events 7 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	0.00% 0/25 • Adverse events were collected during the entire duration of the study: Day 1 through 91.
Nervous system disorders Headache	8.0% 4/50 • Number of events 4 • Adverse events were collected during the entire duration of the study: Day 1 through 91.	0.00% 0/25 • Adverse events were collected during the entire duration of the study: Day 1 through 91.

Additional Information

Jerry M. Stein, Ph.D.

Encore Vision, Inc

Phone: 817-292-6963

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60