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

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: stenfilcon A toric lens; Device: etafilcon A toric lens

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo
• United States
  • California
    • Berkeley, California, United States, 94704
      • Clinical Research Center, University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (Diopter) 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stenfilcon A toric lens; Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.	Device: stenfilcon A toric lens; toric contact lens
Active Comparator: etafilcon A toric lens; Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.	Device: etafilcon A toric lens; toric contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.	Baseline and 1 Week
Handling	Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.	Baseline and 1 Week
Vision	Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.	Baseline and 1 Week
High Visual Acuity	High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.	Baseline and 1 Week
Low Visual Acuity	Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.	Baseline and 1 Week
Lens Surface - Wettability	Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.	Baseline and 1 Week
Lens Surface - Deposits	Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.	Baseline and 1 Week
Corneal Staining, Type	Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior	Baseline and 1 week
Corneal Staining, Extent	Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior	Baseline and 1 week
Conjunctival Staining	Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior	Baseline and 1 week
Lens Durability	Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).	1 Week
Lens Fit Acceptance	Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	Baseline and 1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dryness	Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.	1 Week
Overall Satisfaction	Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.	Baseline and 1 week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Meng C Lin, OD PhD, UC Berkeley Clinical Research Center

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CV-15-02