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

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ClinicalTrials.gov Identifier: NCT02516306
Recruitment Status : Completed
First Posted : August 5, 2015
Results First Posted : April 21, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Encore Vision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Presbyopia
Interventions Drug: EV06 Ophthalmic Solution
Drug: Placebo Ophthalmic Solution
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EVO6 Ophthalmic Solution Placebo
Hide 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 2: Day 8 - 91
Started 50 25
Completed 49 23
Not Completed 1 2
Reason Not Completed
Protocol Violation             1             2
Arm/Group Title EV06 Ophthalmic Solution Placebo Total
Hide 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 Number of Baseline Participants 50 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 25 participants 75 participants
50.1  (3.2) 51.4  (3.0) 50.5  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
Female
33
  66.0%
20
  80.0%
53
  70.7%
Male
17
  34.0%
5
  20.0%
22
  29.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 25 participants 75 participants
50 25 75
1.Primary Outcome
Title Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 49 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame Adverse events were collected during the entire duration of the study: Day 1 through 91.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EVO6 Placebo
Hide 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 (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
EVO6 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EVO6 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/50 (36.00%)      6/25 (24.00%)    
Eye disorders     
Conjunctival hyperaemia  1  0/50 (0.00%)  0 2/25 (8.00%)  2
Eye irritation  1  3/50 (6.00%)  3 0/25 (0.00%)  0
General disorders     
Instillation site pain  1  3/50 (6.00%)  3 1/25 (4.00%)  1
Infections and infestations     
Nasopharyngitis  1  8/50 (16.00%)  8 2/25 (8.00%)  2
Upper respiratory tract infection  1  1/50 (2.00%)  1 2/25 (8.00%)  2
Nervous system disorders     
Disgeusia  1  7/50 (14.00%)  7 0/25 (0.00%)  0
Headache  1  4/50 (8.00%)  4 0/25 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jerry M. Stein, Ph.D.
Organization: Encore Vision, Inc
Phone: 817-292-6963
EMail: summercreekc@gmail.com
Layout table for additonal information
Responsible Party: Encore Vision, Inc.
ClinicalTrials.gov Identifier: NCT02516306    
Other Study ID Numbers: EV-C-002
First Submitted: July 23, 2015
First Posted: August 5, 2015
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: July 2, 2018