A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Aceclidine+tropicamide combination; Aceclidine; Vehicle
Intervention description: Ophthalmic Solution; Ophthalmic Solution; Ophthalmic Solution
Intervention MeSH terms: Tropicamide; Aceclidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 48 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in
      the treatment of early to moderate presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be able and willing to provide written informed consent and sign Health Information
             Portability and Accountability Act (HIPAA) form prior to any study procedure being
             performed;

          2. Be able and willing to follow all instructions and attend study visits;

          3. Be 48-64 years of age of either sex and any race or ethnicity at visit 1;

          4. Be an early to moderate presbyope determined by screening monocular best-corrected
             distance visual acuity (VA) at 45 cm

          5. Be able and willing to avoid all disallowed medications for the appropriate washout
             period and during the study without significant risk to the subject.

        Exclusion Criteria:

          1. Be a female of childbearing potential who is currently pregnant, nursing or planning a
             pregnancy;

          2. Have known contraindications or sensitivity to the use of any of the study
             medications(s) or their components;

          3. Have an active ocular infection at visit 1 (bacterial, viral or fungal), positive
             history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing,
             active ocular inflammation (eg, moderate to severe blepharitis, allergic
             conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;

          4. Have moderate or severe dry eye;

          5. Have clinically significant abnormal lens findings (eg cataract) including early lens
             changes and/or any evidence of a media opacity in either eye;

          6. Have dark-adapted pupillometry measurements of < 4.0 mm in either eye;

          7. Have intraocular pressure (IOP) that is less than 5 millimeters of mercury (mmHg) or
             greater than 22 mmHg in either eye documented at visit 1, or have a prior diagnosis of
             ocular hypertension or glaucoma or currently being treated with any type of topical
             IOP lowering (glaucoma) medication at visit 1;

          8. Have abnormal findings on dilated fundus exam in either eye documented within 3 months
             of visit 1 or a known history of retinal detachment or clinically significant retinal
             disease in either eye;

          9. Have a known history or diagnosis in the past of: iritis, scleritis or uveitis,
             whether active or inactive;

         10. Have had surgical intervention (ocular or systemic) within 6 months prior to visit 1,
             or planned surgical intervention within 30 days after visit 4;

         11. Have undergone refractive eye surgery (incisional keratotomy, photorefractive
             keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub-epithelial
             keratectomy [LASEK]), corneal inlay procedures, cataract extraction, or intraocular
             lens placement;

         12. Use artificial tears or lubricant eye ointment on a daily basis;

         13. Have an inability or refuse to discontinue soft contact lens wear 7 days prior to
             study visit 1 and rigid gas permeable (RGP) contact lens wear 14 days prior to visit 1
             and during the study;

         14. Use any of the following disallowed medications during the 2 weeks (14 days) prior to
             visit 1 and during the study:

               1. narcotic (opiate class) pain medication (eg, codeine, OxyContin®, Vicodin®,
                  Tramadol®)

               2. bladder medication (eg Urecholine®, bethanechol)

               3. antipsychotics

               4. antidepressants

               5. attention -deficit/hyperactivity disorder (ADHD) medications

               6. alpha-blockers (eg, tamsulosin, Flomax®, Jayln®, Uroxatral®, Rapaflo®)

               7. anticholinergics (eg, atropine, belladonna, benztropine, dicyclomine, donepezil,
                  hyoscyamine, propantheline, scopolamine, trihexphenidyl)

               8. muscarinic receptor agonists or cholinergic agonists (eg, Salagen®, Evoxac®)

               9. over-the-counter (OTC) or prescription antihistamines or decongestants

              10. any prescribed topical ophthalmic medications

              11. recreational drug use (eg, marijuana, methadone, heroin, cocaine);

         15. Have a diagnosis of diabetes mellitus or a history of elevated blood sugar;

         16. Have a condition or a situation, which in the Investigator's opinion, may put the
             subject at increased risk, confound study data, or interfere significantly with the
             subject's study participation, including but not limited to unstable: cardiovascular,
             hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic,
             hematologic, neurologic, or psychiatric disease.