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A twin centre, double-masked, randomized, placebo-controlled, repeated administration, crossover study to establish safety, tolerability and efficacy of CSF-1 for the improvement of near vision in presbyopic subjects

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Session Details

Session Title: Moderated Poster Session: What is New and Hot by Great Speakers

Venue: Poster Village: Pod 1

First Author: : S.Rowen USA

Co Author(s): :                  

Abstract Details

Purpose:

To determine the safety, tolerability and significance of any changes in both the monocular and binocular uncorrected visual acuity at both distance and near (UNCVA) in presbyopes using a novel topical pharmacological preparation (CSF-1) in comparison with a placebo.

Setting:

Rambam Hospital, Haifa, Israel and VID Center, Nova Gorica, Slovenia

Methods:

Healthy presbyopes (aged 40-to-65 years) requiring reading glasses with minimal distance refractive errors were enrolled. None had any history of ocular disease or surgery. Each subject was supplied with a bottle of drops either CSF-1 or placebo for daily use for 2 weeks, returned for required tests when a second bottle (the opposite of the one supplied initially) was issued for an additional 2 weeks. Both subjects and staff remained unaware as to whether they were taking active or placebo because all bottles were masked.

Results:

Key success results (n=23, p<0.05): Binocularly: 41% showed ≥2-line improvement using CSF-1 vs. 9% using placebo; 23% showed ≥3-line improvement using CSF-1 vs.4% using placebo; Excluding cases with UNCVA of Jaeger 4 or better at study commencement: (i) 67% showed ≥2-line improvement using CSF-1 vs. 17% using placebo (ii) 42% showed ≥3-line improvement using CSF-1 vs. 8% using placebo. In either OD, or OS, or OU (i.e. success in at least one eye): 64% showed ≥2-line improvement using CSF-1 vs. 26% using placebo; 58% showed ≥3-line improvement using CSF-1 vs. 8% using placebo.

Conclusions:

CSF-1 significantly improves near visual acuity. In all analyses, there was a clear and statistically significant difference between the drug and the placebo. The difference between CSF-1 and placebo was even greater when tested for 3-lines improvement vs. 2-lines improvement, which further supports the clear efficacy of CSF-1. The data indicates that administration of CSF-1 is safe, even when administered repeatedly. There were no reports of any adverse effect, no significant changes in the uncorrected distance visual acuity and CSF-1 was well tolerated.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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