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

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ClinicalTrials.gov Identifier: NCT03201562
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Presbyopia Therapies, LLC

Tracking Information
First Submitted Date  ICMJE June 26, 2017
First Posted Date  ICMJE June 28, 2017
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE April 30, 2017
Actual Primary Completion Date May 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
Proportion of subjects with at least a 3 line (15 letter) improvement in the study eye [ Time Frame: up to 7 hours post-treatment ]
Proportion of subjects with at least a 3 line (15 letter) improvement in the study eye in the measurement of post-treatment monocular best-corrected distance VA at 45 cm compared to baseline monocular best-corrected distance VA at 45 cm up to 7 hours post-treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03201562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
Official Title  ICMJE A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: PRX-100
    Ophthalmic Solution
  • Drug: PRX-100 Component #1
    Ophthalmic Solution
  • Drug: PRX-100 Vehicle
    Ophthalmic Solution
Study Arms  ICMJE
  • Experimental: PRX-100 Ophthalmic Solution
    Intervention: Drug: PRX-100
  • Active Comparator: PRX-100 Component #1 Ophthalmic Solution
    Intervention: Drug: PRX-100 Component #1
  • Sham Comparator: PRX-100 Vehicle Ophthalmic Solution
    Intervention: Drug: PRX-100 Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
58
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
34
Actual Study Completion Date  ICMJE May 20, 2018
Actual Primary Completion Date May 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 48 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03201562
Other Study ID Numbers  ICMJE PRX100.FDAIIb
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Presbyopia Therapies, LLC
Study Sponsor  ICMJE Presbyopia Therapies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
PRS Account Presbyopia Therapies, LLC
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP