A Phase 3 interventional study of Pilocarpine Ophthalmic administered with the Optejet dispenser and Placebo administered with the Optejet dispenser in Presbyopia, sponsored by Eyenovia Inc.. Completed at 9 sites in United States. Open to participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Eyenovia Inc. · Phase 3, Interventional, and Treatment
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 145 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Eyenovia Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2% pilocarpine ophthalmic spray administered with the Optejet dispenser
Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser
Placebo ophthalmic spray administered with the Optejet dispenser
Combination Product: Placebo administered with the Optejet dispenser
Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser
Also known as: MicroLine
Vehicle ophthalmic solution administered with the Optejet dispenser
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA)
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.
Time frame: 120 minutes post-dosing
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Eyenovia Inc.