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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.

Tracking Information
First Submitted Date  ICMJE July 23, 2015
First Posted Date  ICMJE August 5, 2015
Results First Submitted Date  ICMJE March 10, 2017
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE September 16, 2015
Actual Primary Completion Date March 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
Distance Corrected Near Visual Acuity (DCNVA) [ Time Frame: 90 days ]
Is there a change in the DCNVA score?
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: 90 days ]
Is there a change in the BCDVA score?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 3, 2015)
  • Slit lamp findings [ Time Frame: 90 days ]
    Change from baseline in Slit Lamp examination
  • Fundus findings [ Time Frame: 90 days ]
    Change from baseline in Fundus examination
  • Intraocular pressure [ Time Frame: 90 days ]
    Is there a change in the intraocular pressure?
  • Subjective accommodative amplitude by defocus curves [ Time Frame: 90 days ]
    Is there a change in the subjective accommodative amplitude by defocus curves?
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: EV06 Ophthalmic Solution
    Other Name: Active treatment
  • Drug: Placebo Ophthalmic Solution
    Other Name: Inactive control (vehicle)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: EV06 Ophthalmic Solution
  • 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.
    Intervention: Drug: Placebo Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
75
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2015)
72
Actual Study Completion Date  ICMJE March 10, 2016
Actual Primary Completion Date March 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02516306
Other Study ID Numbers  ICMJE EV-C-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Encore Vision, Inc.
Study Sponsor  ICMJE Encore Vision, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Expert Clinical Project Lead Ophthalmology Encore Vision, Inc.
PRS Account Encore Vision, Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP