Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

Completed · Not applicable

Conditions studied: Presbyopia

In brief

The primary objective of this study is to evaluate the distance, intermediate and near visual performance of Clerio designed single vision and Clerio designed LIRIC modified bifocal lenses (+2.00D add) compared to commercially available single vision and multifocal lenses.

Key facts

Study ID

NCT03653715

Run by

Clerio Vision, Inc.

People needed

30

Starts

2018-08-06

Expected to finish

2018-10-12

Last updated by the study team

2019-04-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
• Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
• Willing and able to comply with all study instructions/procedures.
• Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25 (0.10 logMAR).
• Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Previous experience with contact lenses.
• Distance spectacle spherical correction in at least one eye within +/- 5D of the study lens power (-3.00D).
• Habitual spectacle addition (at 40cm) of at least +1.00D.
• Refractive astigmatism less than -2.75D.
• Most recent complete eye examination was within the last 24 months of the date of study completion.

You may not qualify if…

• Currently participating in any drug or device clinical investigation during the period of study participation.
• Active anterior segment ocular disease or using any ocular medication for anterior segment disease (e.g. conjunctivitis, dry-eye disease).
• Current or past condition that might have caused corneal distortion or anterior surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium, pellucid marginal degeneration)
• Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping Endothelial Keratoplasty (DSEK) etc.).
• Considered by the Investigator to not be a suitable candidate for participation.

Where it is running

• Clerio Vision Research Clinic — Rochester, New York, United States

Full record on ClinicalTrials.gov

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