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

Not Applicable

Completed

Conditions: Astigmatism

Interventions: Device: stenfilcon A toric lens
Device: etafilcon A toric lens

Registration Number: NCT02410824

Lead Sponsor: Coopervision, Inc.

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
stenfilcon A toric lens	stenfilcon A toric lens	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
etafilcon A toric lens	etafilcon A toric lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.

Primary Outcome Measures

Name	Time	Method
Comfort	Baseline and 1 Week	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.
Handling	Baseline and 1 Week	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.
Vision	Baseline and 1 Week	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.
High Visual Acuity	Baseline and 1 Week	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.
Low Visual Acuity	Baseline and 1 Week	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.
Lens Surface - Wettability	Baseline and 1 Week	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.
Lens Surface - Deposits	Baseline and 1 Week	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.
Corneal Staining, Type	Baseline and 1 week	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
Corneal Staining, Extent	Baseline and 1 week	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
Conjunctival Staining	Baseline and 1 week	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
Lens Durability	1 Week	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).
Lens Fit Acceptance	Baseline and 1 Week	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.

Secondary Outcome Measures

Name	Time	Method
Overall Satisfaction	Baseline and 1 week	Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
Dryness	1 Week	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.

Trial Locations

Locations (2): Center for Contact Lens Research, University of Waterloo
🇨🇦
Waterloo, Ontario, Canada
Clinical Research Center, University of California, Berkeley
🇺🇸
Berkeley, California, United States