HyperopiaPhase 1/2NCT04883996
A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or Hyperopia
A Phase 1/2 study testing 1% EXP039 in people with Hyperopia and Myopia, run by Canyon City Eyecare at 1 site in United States.
Trial summary
Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants with Myopia or Hyperopia Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- 1% EXP039
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Aug 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 to ≤80 years
- 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
- Low-to-moderate hyperopia (SER of +0.50D to +2.00D) or myopia (SER of -0.50 D to -4.00D) at Screening
- Between-eye SER difference of no more than 0.50D
- Best-corrected distance visual acuity better than or equal to 20/20 in both eyes at Screening
- Astigmatism in each eye of less than or equal to 0.75D with manifest refraction at Screening
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- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening
- 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.
- Males must not donate sperm for at least 90 days after the last dose of study drug
- Participants must have the ability and willingness to attend the necessary visits
- 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.
Who cannot join
- 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
- Moderate or severe dry eye as defined by corneal fluorescein staining score of ≥3 on Oxford scale at Screening
- 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)
- Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
- Intraocular pressure (IOP) <8 mmHg or >23 mmHg in either eye or history of glaucoma or ocular hypertension
- Any clinically significant abnormal lens finding (e.g., cataract, loose zonules, exfoliation, pseudoexfoliation)
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- History of any intraocular surgery including cataract surgery or phakic intraocular lens surgery
- 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
- 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
- Clinically significant strabismus or diplopia
- History of stereo vision difficulties
- History of optic neuropathy or amblyopia in either eye
- Use of orthokeratology contact lenses within the past 1 month prior to EXP039 dosing on Day 1
- Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
- Planned use of any contact lenses during the study
- Allergy to pilocarpine or any of its excipients
- Serious systemic illness that, in the opinion of the Investigator's, would render the participant ineligible
- Pre-planned hospitalization or ocular or systemic surgery during the study period
- 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
- 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
- Unwilling or unable to complete study procedures or to be followed up for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- 1% EXP039, Saline control
- Keywords
- Hyperopia, Myopia, Visual Acuity, Mesopic
- Medical subject headings
- Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% EXP039Drug
Also called Isopto® Carpine
1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL),
Saline controlOther
Also called Saline
Saline
| Study group | Role | What they receive |
|---|---|---|
| EXP039 | Active comparator | 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. Receives: Drug: 1% EXP039 |
| Saline control | Placebo comparator | 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. Receives: Other: Saline control |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDVA
Mesopic high-contrast uncorrected distance visual acuity
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Dec 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canyon City Eyecare
- Sponsor type
- University, hospital or other
- Collaborators
- Nevakar, Inc.
- Responsible party
- Sponsor
- Investigators
- Milton Hom, OD FAAO, Principal investigator, Canyon City Eyecare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883996
- Sponsor's protocol ID
- CP-EXP039-0001
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04883996
- Acronym / sponsor ID
- CP-EXP039-0001
- Keywords
- Hyperopia, Myopia, Visual Acuity, Mesopic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Canyon City EyecareUniversity, hospital or other
- Collaborators
- Nevakar, Inc.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants with Myopia or Hyperopia
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXP039 | Active comparator | Drug: 1% EXP039At 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. |
| Saline control | Placebo comparator | Other: Saline controlAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 to ≤80 years
- 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
- Low-to-moderate hyperopia (SER of +0.50D to +2.00D) or myopia (SER of -0.50 D to -4.00D) at Screening
- Between-eye SER difference of no more than 0.50D
- Best-corrected distance visual acuity better than or equal to 20/20 in both eyes at Screening
Key exclusion criteria (21 listed)
- 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
- Moderate or severe dry eye as defined by corneal fluorescein staining score of ≥3 on Oxford scale at Screening
- 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)
- Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
- Intraocular pressure (IOP) <8 mmHg or >23 mmHg in either eye or history of glaucoma or ocular hypertension
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 |
|---|---|---|
| 1% EXP039Also: Isopto® Carpine1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL), | Drug | EXP039 |
| Saline controlAlso: SalineSaline | Other | Saline control |
Primary outcome
UDVA
Time frame: 1 hour
Mesopic high-contrast uncorrected distance visual acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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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.
Milton Hom, OD FAAO principal investigator
Canyon City Eyecare
1 site 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 1% EXP039 in people with Hyperopia and Myopia, run by Canyon City Eyecare at 1 site 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 11 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
UDVA (time frame: 1 hour). 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 13 May 2021.