An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)

Sponsor
Orasis Pharmaceuticals Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04599933
Collaborator
(none)
300
Enrollment
16
Locations
2
Arms
13.8
Anticipated Duration (Months)
18.8
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration)
Actual Study Start Date :
Oct 19, 2020
Anticipated Primary Completion Date :
Dec 7, 2021
Anticipated Study Completion Date :
Dec 14, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: CSF-1

One drop bilaterally twice daily for approximately 2 weeks.

Drug: CSF-1
One drop bilaterally twice daily for approximately 2 weeks.

Placebo Comparator: Vehicle

One drop bilaterally twice daily for approximately 2 weeks.

Drug: Vehicle
One drop bilaterally twice daily for approximately 2 weeks.

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m. [Day 8]

Secondary Outcome Measures

  1. Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m. [Day 1/Day 8/Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subjects must have presbyopia.
Exclusion Criteria:
Subjects must not:
  • Have any contraindications to the study medications or diagnoses that would confound the study.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Orasis Investigative SiteSun CityArizonaUnited States85351
2Orasis Investigative SiteGlendaleCaliforniaUnited States91204
3Orasis Investigative SiteFort MyersFloridaUnited States33901
4Orasis Investigative SiteMount DoraFloridaUnited States32757
5Orasis Investigative SiteMorrowGeorgiaUnited States30260
6Orasis Investigative SiteOverland ParkKansasUnited States66210
7Orasis Investigative SiteLouisvilleKentuckyUnited States40206
8Orasis Investigative SiteKansas CityMissouriUnited States64133
9Orasis Investigative SiteSaint LouisMissouriUnited States63131
10Orasis Investigative SiteHendersonNevadaUnited States89052
11Orasis Investigative SiteElizabeth CityNorth CarolinaUnited States27909
12Orasis Investigative SiteCranberry TownshipPennsylvaniaUnited States16066
13Orasis Investigative SiteWilkes-BarrePennsylvaniaUnited States18702
14Orasis Investigative SiteRapid CitySouth DakotaUnited States57701
15Orasis Investigative SiteMemphisTennesseeUnited States38119
16Orasis Investigative SiteEl PasoTexasUnited States79902

Sponsors and Collaborators

  • Orasis Pharmaceuticals Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Orasis Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT04599933
Other Study ID Numbers:
  • 20-150-0002
First Posted:
Oct 23, 2020
Last Update Posted:
Aug 9, 2021
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2021