Study of safety and efficacy of UNR844 in subjects with presbyopia

Phase 2

Active, not recruiting

• Conditions: Presbyopia

• Registration Number: JPRN-jRCT2051210054
• Lead Sponsor: Yamada Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Phakic male or female participants aged 45 to 55 years, inclusive, at the Screening visit.
- Monocular and binocular distance-corrected near visual acuity at 40 cm distance worse than 0.3 logMAR at the Screening and Baseline visits.
- Binocular distance-corrected near visual acuity at baseline must not be different by more than 0.1 logMAR from the corresponding assessment at the Screening visit.
- Need a minimum near addition prescription of +1.00 D or more to achieve binocular DCNVA of at least 0.0 logMAR at 40 cm distance, as assessed by the Investigator, at the Screening visit.

Exclusion Criteria

- Best-corrected distance visual acuity worse than 0.0 logMAR at 4 m distance in either eye at the Screening visit.
- Spherical equivalent greater than +4.0 D or less than -4.0 D, based on manifest refraction, in either eye at the Screening visit.
- Astigmatism of greater than 1.25 D, based on manifest refraction, in either eye at the Screening visit.
- Difference in manifest refraction spherical equivalent of greater than 0.75 D between eyes at the Screening visit.
- Any ocular or systemic condition that, in the opinion of the Investigator, would jeopardize subject safety, has an impact on visual acuity, affects study assessments or validity of study results

Study & Design

• Study Type: Interventional
• Study Design: Not specified