A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia

NCT ID: NCT03201562

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2018-05-20

Brief Summary

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

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aceclidine+tropicamide combination

Aceclidine+tropicamide combination single dose (PRX-100 Ophthalmic Solution)

Group Type: EXPERIMENTAL

Aceclidine+tropicamide combination

Intervention Type: DRUG

Ophthalmic Solution

Aceclidine

Aceclidine single dose

Group Type: ACTIVE_COMPARATOR

Aceclidine

Intervention Type: DRUG

Ophthalmic Solution

Vehicle

Vehicle single dose

Group Type: SHAM_COMPARATOR

Vehicle

Intervention Type: DRUG

Ophthalmic Solution

Interventions

Aceclidine+tropicamide combination

Ophthalmic Solution

Intervention Type: DRUG

Aceclidine

Ophthalmic Solution

Intervention Type: DRUG

Vehicle

Ophthalmic Solution

Intervention Type: DRUG

Other Intervention Names

PRX-100

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.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LENZ Therapeutics, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRX100.FDAIIb

Identifier Type: -

Identifier Source: org_study_id