A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

Myopia Clinical Trial

Official title:

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345811
• Other study ID #: CV-15-01
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Description:

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer

• Has read and signed an information consent letter

• Is willing and able to follow instructions and maintain the appointment schedule;

• Is an adapted soft contact lens wearer

• Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)

• Has no more than 0.75 diopters of refractive astigmatism

• Willing to wear contact lens in both eyes

• Has manifest refraction visual acuities (VA) equal to or better than logMAR 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 as acceptable

Exclusion Criteria:

• Is participating in any concurrent clinical or research study

• Has any known active* ocular disease and/or infection

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)

• Is aphakic

• Has undergone refractive error surgery

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Sapphire
silicone-hydrogel contact lens
• senofilcon A
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario
United States	Clinical Research Center, University of California, Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision Quality	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)	Baseline (10 minutes post lens settling at dispense)
Primary	Vision Quality	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)	2 weeks - During the Day
Primary	Vision Quality	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)	2 weeks - End of Day
Primary	Subjective Rating for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	Baseline - 10 minutes post lens settling
Primary	Subjective Rating for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	2-weeks - During the Day
Primary	Subjective Rating for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	2-weeks - End of Day
Primary	Lens Surface Wettability	Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)	Baseline (10 minutes post lens settling)
Primary	Lens Surface Wettability	Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)	2 weeks
Primary	Surface Deposits	Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)	Baseline (10 minutes post lens settling)
Primary	Surface Deposits	Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)	2-weeks
Primary	Lens Handling (Ease of Insertion)	Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.	2 weeks
Primary	Lens Handling (Ease of Removal)	Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.	2 weeks
Primary	Subjective Preference for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	Baseline - 10 minutes post lens settling
Primary	Subjective Preference for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	2 weeks