Pupil ConstrictionEarly Phase 1NCT06783686
Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects With Presbyopia
A Early Phase 1 study testing NV701 and Pilocarpine 1.25% Eye drop in people with Pupil Constriction, run by Novus Vision LLC at 2 sites in United States.
Trial summary
Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Pupil Constriction
- What is being tested?
- NV701 and Pilocarpine 1.25% Eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2025to 7 May 2025
- Phase
- Early Phase 1
- 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 40-55 years with presbyopia
- Able to understand and willing to sign the informed consent for the study
- Resting mesopic pupil diameter of >4 mm in both eyes
- Change in mesopic pupil diameter of >1 mm after 1 hour in response to pilocarpine 1.25% in both eyes
- Willing to abstain from contact lens use for 7 days before the study visit
- Women of childbearing age must have a negative urine pregnancy test at the screening visit and be willing to use a reliable method of birth control during the study
Who cannot join
- Anisocoria >1 mm in photopic or mesopic conditions
- High myopia (-6.00 diopters or greater)
- Any iris abnormality making it difficult to judge pupil diameter as determined by the principal investigator
- Known allergy to any of the study products or medications
- Concurrent use of any topical prescription ophthalmic products
- History of uveitis or intraocular inflammation
Show all 19Show fewer
- Inability to complete any of the study procedures
- History of ocular surgery other than LASIK or PRK
- History of retinal tear or retinal detachment
- Presence of retinal lattice degeneration, operculated hole, or other retinal pathology on screening exam.
- History of punctal plugs or punctal cautery in one or both eyes
- History of nasolacrimal duct surgery in one or both eyes
- History of blepharoplasty or ptosis surgery in one or both eyes
- History of glaucoma, glaucoma suspect or ocular hypertension diagnosis
- History of acute angle closure or laser peripheral iridotomy
- History of moderate or severe dry eye disease
- Females who are pregnant, nursing, or planning a pregnancy during the study
- Females of childbearing potential and males with partners of childbearing potential who do not agree to use reliable contraception during the study
- Uncontrolled systemic disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona Eye Center
Chandler, Arizona, 85224
Global Research Management, Inc
Glendale, California, 91204
About this study
Official title: Effect on Pupil Size After One-time Administration of NV701 (Pilocarpine 1.25%) vs. Vuity (Pilocarpine 1.25%)
Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.
- Conditions
- Pupil Constriction
- Being tested
- NV701, Pilocarpine 1.25% Eye drop
- Medical subject headings
- Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NV701Drug
eye drop
Pilocarpine 1.25% Eye dropDrug
eye drop
| Study group | Role | What they receive |
|---|---|---|
| NV701 | Experimental | 1 drop of NV701 (1.25% pilocarpine) |
| Vuity | Active comparator | 1 drop of Vuity (1.25% pilocarpine) in contralateral eye Receives: Drug: Pilocarpine 1.25% Eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pupil size over 8 hours
Area under the curve (AUC) of the change in mesopic pupil diameter over 8 hours after eye drop dosing
Measured: 8 hours
Secondary outcomes (1)
Mesopic pupil diameter difference
Absolute difference in mesopic pupil diameter at 1, 2, 3, 4, 5, 6, 7, and 8 hours after administration
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start30 Jan 2025
- Primary completion4 Apr 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupil ConstrictionStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novus Vision LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783686
- Sponsor's protocol ID
- NV701-02
- Status last verified
- Aug 2025
- First submitted
- 14 Jan 2025
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Pupil Size After One-time Administration of NV701 (Pilocarpine 1.25%) vs. Vuity (Pilocarpine 1.25%)
- ClinicalTrials.gov ID
- NCT06783686
- Acronym / sponsor ID
- NV701-02
- Conditions
- Pupil Constriction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novus Vision LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 20 Jan 2025 (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.
Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NV701 | Experimental | –1 drop of NV701 (1.25% pilocarpine) |
| Vuity | Active comparator | Drug: Pilocarpine 1.25% Eye drop1 drop of Vuity (1.25% pilocarpine) in contralateral eye |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 40-55 years with presbyopia
- Able to understand and willing to sign the informed consent for the study
- Resting mesopic pupil diameter of >4 mm in both eyes
- Change in mesopic pupil diameter of >1 mm after 1 hour in response to pilocarpine 1.25% in both eyes
- Willing to abstain from contact lens use for 7 days before the study visit
Key exclusion criteria (19 listed)
- Anisocoria >1 mm in photopic or mesopic conditions
- High myopia (-6.00 diopters or greater)
- Any iris abnormality making it difficult to judge pupil diameter as determined by the principal investigator
- Known allergy to any of the study products or medications
- Concurrent use of any topical prescription ophthalmic products
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 |
|---|---|---|
| NV701eye drop | Drug | – |
| Pilocarpine 1.25% Eye dropeye drop | Drug | Vuity |
Primary outcome
Change in pupil size over 8 hours
Time frame: 8 hours
Area under the curve (AUC) of the change in mesopic pupil diameter over 8 hours after eye drop dosing
1 secondary outcome
Mesopic pupil diameter difference
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NV701 and Pilocarpine 1.25% Eye drop in people with Pupil Constriction, run by Novus Vision LLC at 2 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 6 inclusion and 19 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pupil size over 8 hours (time frame: 8 hours). 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 5 Sep 2025.