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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-16

Study Completion Date

2016-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

NCT05114486

Presbyopia

COMPLETED PHASE3

Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

NCT04657172

Presbyopia

COMPLETED PHASE3

Pilocarpine and Brimonidine in Patients With Monofocal Lenses

NCT03825081

Presbyopia Pseudophakia

UNKNOWN EARLY_PHASE1

Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses

NCT05624320

Presbyopia

WITHDRAWN PHASE4

A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia

NCT03201562

Presbyopia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Presbyopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

EV06 Ophthalmic Solution

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo Ophthalmic Solution

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EV06 Ophthalmic Solution

Intervention Type DRUG

Placebo Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active treatment Inactive control (vehicle)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No