A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

Completed · Not applicable

Conditions studied: Astigmatism

In brief

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product.

Key facts

Study ID

NCT02555098

Run by

CooperVision, Inc.

People needed

23

Starts

2015-09-01

Expected to finish

2016-04-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A person is eligible for inclusion in the study if they:
• Are at least 18 years of age and have full legal capacity to volunteer;
• Have read and signed an information consent letter;
• Are willing and able to follow instructions and maintain the appointment schedule;
• Are an adapted soft contact lens wearer;
• Require spectacle lens powers in both eyes;
• Sphere: between -1.75 to -6.00 diopters and
• Astigmatism: between -1.00 to -2.25 and
• Axis: 180 ± 20 degrees
• Are willing to wear contact lenses in both eyes;
• Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
• To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.

You may not qualify if…

• A person will be excluded from the study if they:
• Are participating in any concurrent clinical or research study;
• Have any known active* ocular disease and/or infection;
• Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
• Are aphakic;
• Have undergone refractive error surgery;

Where it is running

• Family Eye Care Center — Campbell, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.