Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Astigmatism Clinical Trial

Official title:

Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410824
• Other study ID #: CV-15-02
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: July 27, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Description:

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to enfilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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 a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye

• Has spectacle astigmatism: -0.50 to -1.50D cylinder (Axis: 90±20, 180±20 in both eyes);

• Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;

• 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 (by verbal confirmation at the screening visit);

• Is aphakic;

• Has undergone refractive error surgery

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• stenfilcon A
Each subject will be randomized to wear either the test or control as a matched pair first and then crossover to the alternate pair.
• etafilcon A
Each subject will be randomized to wear either the test or control as a matched pair first and then crossover to the alternate pair.

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	Subjective ratings for comfort	Subjective ratings of lens performance for comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)	1 Week	No