Pupil Constriction
Conditions
Brief 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.
Interventions
DRUGNV701
eye drop
eye drop
Sponsors
Novus Vision LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pupil size over 8 hours | 8 hours | Area under the curve (AUC) of the change in mesopic pupil diameter over 8 hours after eye drop dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mesopic pupil diameter difference | 8 hours | Absolute difference in mesopic pupil diameter at 1, 2, 3, 4, 5, 6, 7, and 8 hours after administration |
Countries
United States
Outcome results
None listed