ACECLIDINE SOLN,OPH
Clinical Criteria Summary
Indication
- Presbyopia
Patient Population & Clinical Characteristics
- Adults aged 45-75 years of either sex
- Refractive range from -4.00 to +1.00 D sphere
- Astigmatism up to 2.00 D
- Spherical equivalent no more myopic than -4.00 D
Administration & Dosing
- Ophthalmic solution: aceclidine 1.44% in a single-dose vial
- Instill 1 drop in each eye, wait 2 minutes and instill a second drop in each eye once daily from the same single-dose vial
- Contact lenses should be removed prior to aceclidine administration
Contraindications
- None explicitly stated
Warnings & Precautions
- Blurred vision
- Risk of retinal tear/detachment
- Iritis
- Hypersensitivity
- Potential for eye injury and contamination
Exclusion Criteria
- Female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy
- Known contraindications or sensitivity to the use of any study medications or their components
- Active ocular infection, positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing active ocular inflammation
- Moderate or severe dry eye
- Clinically significant abnormal lens findings