Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects With Presbyopia
Completed · Early Phase 1
Conditions studied: Pupil Constriction
In brief
Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.
Key facts
- Study ID
- NCT06783686
- Run by
- Novus Vision LLC
- People needed
- 55
- Starts
- 2025-01-30
- Expected to finish
- 2025-05-07
- Last updated by the study team
- 2025-09-05
Who can join
Age: 40 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Arizona Eye Center — Chandler, Arizona, United States
- Global Research Management, Inc — Glendale, California, United States
Full record on ClinicalTrials.gov
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