CompletedPhase 3

Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia

China300 participantsStarted 2023-09-27

Plain-language summary

A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

Who can participate

Age range45 Years – 75 Years

SexALL

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Inclusion criteria

✓. Be able and willing to provide written informed consent prior to any study procedure being performed;
✓. Be able and willing to follow all instructions and attend all study visits;
✓. Be 45-75 years of age of either sex at Visit 1;
✓. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder in both eyes determined by manifest refraction documented at Visit 1;
✓. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
✓. Have +1.00 D to -4.00 D manifest refraction spherical equivalent（MRSE）of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1.
✓. Be presbyopic as determined at Visit 2 baseline

Exclusion criteria

✕. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
✕. Have known contraindications or sensitivity to the use of any of the study medications or their components;
✕. Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
✕. Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
✕. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

What they're measuring

Best-corrected distance visual acuity (BCDVA) at 40 cm

Timeframe: 3 hours post-treatment in the study eye at Visit 2 (Day 1）

Trial details

NCT IDNCT06045299

SponsorCorxel Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-19

View on ClinicalTrials.gov More Presbyopia trials