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

NCT03201562 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PRX100.FDAIIb
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye

  Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population

  1 hour post-treatment

Study Arms (3)

Aceclidine+tropicamide combination

EXPERIMENTAL

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

Drug: Aceclidine+tropicamide combination

Aceclidine

ACTIVE COMPARATOR

Aceclidine single dose

Drug: Aceclidine

Vehicle

SHAM COMPARATOR

Vehicle single dose

Drug: Vehicle

Interventions

Aceclidine+tropicamide combination DRUG

Ophthalmic Solution

Also known as: PRX-100

Aceclidine+tropicamide combination

Aceclidine DRUG

Ophthalmic Solution

Aceclidine

Vehicle DRUG

Ophthalmic Solution

Vehicle

Eligibility Criteria

• Age: 48 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Be able and willing to follow all instructions and attend study visits;
• Be 48-64 years of age of either sex and any race or ethnicity at visit 1;
• Be an early to moderate presbyope determined by screening monocular best-corrected distance visual acuity (VA) at 45 cm
• Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study without significant risk to the subject.

You may not qualify if:

• Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
• Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
• 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;
• Have moderate or severe dry eye;
• Have clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of a media opacity in either eye;
• Have dark-adapted pupillometry measurements of \< 4.0 mm in either eye;
• 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;
• 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;
• Have a known history or diagnosis in the past of: iritis, scleritis or uveitis, whether active or inactive;
• Have had surgical intervention (ocular or systemic) within 6 months prior to visit 1, or planned surgical intervention within 30 days after visit 4;
• 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;
• Use artificial tears or lubricant eye ointment on a daily basis;
• 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;
• Use any of the following disallowed medications during the 2 weeks (14 days) prior to visit 1 and during the study:
• narcotic (opiate class) pain medication (eg, codeine, OxyContin®, Vicodin®, Tramadol®)

Sponsors & Collaborators

• LENZ Therapeutics, Inc: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Presbyopia

Interventions

aceclidine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jerry Horn, MD
• Organization: Presbyopia Therapies, LLC

visionxcl@icloud.com

(847)-772-8885

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: April 30, 2017
• Primary Completion: May 20, 2018
• Study Completion: May 20, 2018
• Last Updated: September 22, 2022
• Results First Posted: April 19, 2021

Record last verified: 2022-09

Locations

US (1)