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

NCT02555098 | Completed Results

• 1 other identifier: CV-15-15
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (10)

• Subjective Ratings for Comfort

  Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

  Baseline (10 minutes post lens settling)

• Subjective Ratings for Comfort

  Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

  2 weeks

• Subjective Ratings for Comfort Preference

  Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

  Baseline (10 minutes post lens settling)

• Subjective Ratings for Comfort Preference

  Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

  2 weeks

• Subjective Assessment of Visual Quality

  Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

  Baseline (10 minutes post lens settling)

• Subjective Assessment of Visual Quality

  Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

  2 weeks

• Subjective Assessment of Overall Satisfaction

  Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

  Baseline (10 minutes post lens settling)

• Subjective Assessment of Overall Satisfaction

  Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

  2 weeks

• Subjective Overall Preference

  Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

  Baseline (10 minutes post lens settling)

• Subjective Overall Preference

  Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

  2 weeks

Study Arms (2)

Sapphire contact lenses

EXPERIMENTAL

Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

Device: Sapphire contact lenses

senofilcon A

ACTIVE COMPARATOR

Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

Device: senofilcon A contact lenses

Interventions

Sapphire contact lenses DEVICE

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Sapphire contact lenses

senofilcon A contact lenses DEVICE

Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

senofilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Family Eye Care Center

Campbell, California, 95008, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen
• Organization: CooperVision, Inc.

mnguyen@coopervision.com

925-730-6716

Study Officials

• Michel Guillon

  Ocular Technology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 21, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 19, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-09

Locations

US (1)