A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or Hyperopia

May 11, 2021 updated by: Canyon City Eyecare

A Phase 1/2, Randomized, Placebo Controlled Crossover Study to Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants With Myopia or Hyperopia

Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants with Myopia or Hyperopia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To characterize the effect of pupillary miosis as achieved with EXP039 1% ophthalmic solution in terms of mean number of lines (Early Treatment Diabetic Retinopathy Study [ETDRS]) of improvement from baseline in binocular (both eyes open) mesopic high-contrast uncorrected distance visual acuity (UDVA) at 1-hour post treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Azusa, California, United States, 91702
        • Canyon City Eyecare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 to ≤80 years
  2. Participants must be in good general health, with no significant medical problems that, in the opinion of the investigator, would preclude participation in the trial, at Screening and/or before administration of the dose of study drug
  3. Low-to-moderate hyperopia (SER of +0.50D to +2.00D) or myopia (SER of -0.50 D to -4.00D) at Screening
  4. Between-eye SER difference of no more than 0.50D
  5. Best-corrected distance visual acuity better than or equal to 20/20 in both eyes at Screening
  6. Astigmatism in each eye of less than or equal to 0.75D with manifest refraction at Screening
  7. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening
  8. WOCBP must be non-pregnant and non-lactating, and must use a medically approved, highly effective contraception method from Screening until study completion, including the follow up period. Female participants who are in same sex relationships are not required to use contraception.Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must use a medically approved, highly effective contraceptive method from Screening until study completion, including the follow-up period.
  9. Males must not donate sperm for at least 90 days after the last dose of study drug
  10. Participants must have the ability and willingness to attend the necessary visits
  11. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Exclusion Criteria:

  1. Any central corneal abnormality (e.g., keratoconus, Pellucid marginal degeneration, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that is likely to interfere with visual acuity
  2. Moderate or severe dry eye as defined by corneal fluorescein staining score of ≥3 on Oxford scale at Screening
  3. Any clinically significant pupillary or iris abnormality (e.g., anisocoria of >1 mm between eyes at Screening or baseline, abnormal pupil shape in either eye, iris transillumination defects, or any congenital or traumatic defect of the iris)
  4. Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
  5. Intraocular pressure (IOP) <8 mmHg or >23 mmHg in either eye or history of glaucoma or ocular hypertension
  6. Any clinically significant abnormal lens finding (e.g., cataract, loose zonules, exfoliation, pseudoexfoliation)
  7. History of any intraocular surgery including cataract surgery or phakic intraocular lens surgery
  8. History in either eye of previous corneal inlay, full- or partial-thickness corneal transplant, radial keratotomy or any corneal surgery including laser-based corneal refractive surgery
  9. Any clinically significant abnormal finding on dilated fundus examination in either eye or known history of retinal detachment, retinal trauma, retinal or vitreal surgery, or clinically significant retinal disease in either eye
  10. Clinically significant strabismus or diplopia
  11. History of stereo vision difficulties
  12. History of optic neuropathy or amblyopia in either eye
  13. Use of orthokeratology contact lenses within the past 1 month prior to EXP039 dosing on Day 1
  14. Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
  15. Planned use of any contact lenses during the study
  16. Allergy to pilocarpine or any of its excipients
  17. Serious systemic illness that, in the opinion of the Investigator's, would render the participant ineligible
  18. Pre-planned hospitalization or ocular or systemic surgery during the study period
  19. History of any substance abuse (alcohol and/or illegal drugs) and not willing to abstain from drug(s) and reasonably limit alcohol consumption to approximately 2 alcoholic beverages per day during the 30-day study period
  20. Participation in any other study of investigational therapy during the study period or within the last 30 days or 5 half-lives, whichever is longer
  21. Unwilling or unable to complete study procedures or to be followed up for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: EXP039
At Visit 1, single dose 1 drop of EXP039 1% is adminstered, followed by washout period of 1-10 days. Subsequently, subjects will crossover to single dose 1 drop saline at Visit 2.
Drug: 1% EXP039
1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL),
Other Names:
  • Isopto® Carpine
Placebo Comparator: Saline control
At Visit 1, single dose 1 drop of saline is adminstered, followed by washout period of 1-10 days. Subsequently, subjects will crossover to single dose 1 drop EXP039 1% at Visit 2.
Other: Saline control
Saline
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
UDVA
Time Frame: 1 hour
Mesopic high-contrast uncorrected distance visual acuity
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canyon City Eyecare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nevakar, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Milton Hom, OD FAAO, Canyon City Eyecare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-EXP039-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings