Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in … (NCT06783686) | Clinical Trial Compass
CompletedEarly Phase 1
Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects With Presbyopia
United States55 participantsStarted 2025-01-30
Plain-language 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.
Who can participate
Age range40 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 la…