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PresbiDrops (CSF-1) in Presbyopia
NCT02745223Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2016
- Primary completion
- Jun 2017
- Countries
- 1
- Sponsor
- Orasis Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- pilocarpine
- Conditions
- presbyopia
01
Overview
Phase 2, randomised, double-blind trial in presbyopia comparing PresbiDrops (CSF-1) with Placebo (2 arms). Primary endpoints: Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity at 14 days and Mean change from Baseline in the number of lines correctly identified in uncorrected near distance visual acuity at 14 days. Started Jul 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PresbiDrops (CSF-1)
1 drop in each eye each morning
Placebo
1 drop in each eye each morning
03
Who it enrols
Adults aged 40-65 with presbyopia, normal distance vision (20/20), and dependence on reading glasses (> +1.00 D). Excludes those with cataracts, severe dry eye, or history of ocular surgery.
04
Endpoints
Primary
Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity
Mean change from Baseline in the number of lines correctly identified in uncorrected near distance visual acuity
Secondary
Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected intermediate distance visual acuity
Mean change from Baseline in the number of lines correctly identified in uncorrected intermediate distance visual acuity
Change from Baseline in the depth of focus at distance and near
Change from Baseline in uncorrected distance visual acuity
Change from Baseline in the need for glasses
Change from Baseline in pupil diameter and appearance
Change from Baseline in the stability of pre-corneal tear film
Change from Baseline in visual field
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