PresbyopiaPhase 1/2NCT02516306
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
A Phase 1/2 study testing EV06 Ophthalmic Solution in people with Presbyopia, run by Encore Vision, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- EV06 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Sep 2015to 10 Mar 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sall Research Medical Center, Inc.
Artesia, California, 90701
Total Eye Care
Memphis, Tennessee, 38119
North Valley Eye Medical Group
Mission Hills, California, 91345
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
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
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- EV06 Ophthalmic Solution, Placebo Ophthalmic Solution
- Keywords
- Presbyopia, Vision, UNR844
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV06 Ophthalmic SolutionDrug
Also called Active treatment
Placebo Ophthalmic SolutionDrug
Also called Inactive control (vehicle)
| Study group | Role | What they receive |
|---|---|---|
| EV06 Ophthalmic Solution | Experimental | 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. Receives: Drug: EV06 Ophthalmic Solution |
| Placebo Ophthalmic Solution | Placebo comparator | 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. Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit
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.
Measured: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study start16 Sep 2015
- Primary completion10 Mar 2016
- Study completion10 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Expert Clinical Project Lead Ophthalmology, Study director, Encore Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516306
- Sponsor's protocol ID
- EV-C-002
- Status last verified
- Oct 2017
- First submitted
- 23 Jul 2015
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02516306
- Acronym / sponsor ID
- EV-C-002
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Vision, UNR844
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Encore Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 10 Mar 2016 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV06 Ophthalmic Solution | Experimental | Drug: EV06 Ophthalmic SolutionEV06 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 | Placebo comparator | Drug: Placebo Ophthalmic SolutionPlacebo 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV06 Ophthalmic SolutionAlso: Active treatment | Drug | EV06 Ophthalmic Solution |
| Placebo Ophthalmic SolutionAlso: Inactive control (vehicle) | Drug | Placebo Ophthalmic Solution |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Expert Clinical Project Lead Ophthalmology study director
Encore Vision, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EV06 Ophthalmic Solution in people with Presbyopia, run by Encore Vision, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.