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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02410824
• Collaborator: (none)
• Enrollment: 52
• Locations: 2
• Arms: 2
• Duration (Months): 2
• Patients Per Site: 26
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: stenfilcon A toric lens; Device: etafilcon A toric lens	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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

9. 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

10. 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

11. 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).

12. 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

1. 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.

2. Overall Satisfaction [Baseline and 1 week]

   Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center, University of California, Berkeley	Berkeley	California	United States	94704
2	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Meng C Lin, OD PhD, UC Berkeley Clinical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02410824
• Other Study ID Numbers: CV-15-02
• First Posted: Apr 8, 2015
• Last Update Posted: Aug 21, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Pre-assignment Detail	7 subjects discontinued before lens randomization due to screen failure.

Arm/Group Title	Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens	Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens. stenfilcon A: toric contact lens etafilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens. etafilcon A: toric contact lens stenfilcon A: toric contact lens
Period Title: First Intervention (One Week)
STARTED	22	23
COMPLETED	22	22
NOT COMPLETED	0	1
Period Title: First Intervention (One Week)
STARTED	22	22
COMPLETED	22	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Baseline Characteristics
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair.
Overall Participants	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26 (9)
Sex: Female, Male (Count of Participants)
Female	34 77.3%
Male	10 22.7%
Region of Enrollment (participants) [Number]
Canada	21 47.7%
United States	23 52.3%

Outcome Measures

1. Primary Outcome

Title	Comfort
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	88 (13)	78 (18)
1 week	85 (14)	77 (21)

2. Primary Outcome

Title	Handling
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	87 (12)	81 (16)
1 week	87 (18)	81 (23)

3. Primary Outcome

Title	Vision
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	83 (16)	78 (21)
1 week	86 (17)	83 (17)

4. Primary Outcome

Title	High Visual Acuity
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric lens contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	-0.10 (0.06)	-0.08 (0.06)
1 week	-0.09 (0.07)	-0.09 (0.07)

5. Primary Outcome

Title	Low Visual Acuity
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	-0.08 (0.06)	-0.07 (0.06)
1 week	-0.07 (0.07)	-0.07 (0.07)

6. Primary Outcome

Title	Lens Surface - Wettability
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	3.2 (0.8)	3.4 (0.5)
1 week	3.2 (0.7)	3.3 (0.7)

7. Primary Outcome

Title	Lens Surface - Deposits
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	0.09 (0.23)	0.11 (0.24)
1 week	0.18 (0.28)	0.25 (0.37)

8. Primary Outcome

Title	Corneal Staining, Type
Description	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
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline - Central	0.09 (0.32)	0.09 (0.32)
1 week - Central	0.07 (0.27)	0.02 (0.21)
Baseline - Nasal	0.19 (0.42)	0.19 (0.42)
1 week - Nasal	0.13 (0.54)	0.22 (0.62)
Baseline - Temporal	0.09 (0.28)	0.09 (0.28)
1 week - Temporal	0.01 (0.2)	0.14 (0.42)
Baseline - Superior	0.12 (0.34)	0.12 (0.34)
1 week - Superior	0.36 (0.62)	0.24 (0.49)
Baseline - Inferior	0.56 (0.75)	0.56 (0.75)
1 week - Inferior	0.30 (0.58)	0.49 (0.79)

9. Primary Outcome

Title	Corneal Staining, Extent
Description	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
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline - Central	0.07 (0.30)	0.07 (0.30)
1 week - Central	0.07 (0.26)	0.01 (0.11)
Baseline - Nasal	0.13 (0.30)	0.13 (0.30)
1 week - Nasal	0.06 (0.25)	0.14 (0.36)
Baseline - Temporal	0.09 (0.28)	0.09 (0.28)
1 week - Temporal	0.02 (0.12)	0.13 (0.38)
Baseline - Superior	0.09 (0.27)	0.09 (0.27)
1 week - Superior	0.22 (0.46)	0.20 (0.42)
Baseline - Inferior	0.47 (0.59)	0.47 (0.59)
1 week - Inferior	0.28 (0.55)	0.41 (0.61)

10. Primary Outcome

Title	Conjunctival Staining
Description	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
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline - Nasal	0.36 (0.60)	0.36 (0.60)
1 week - Nasal	1.19 (0.82)	1.49 (0.96)
Baseline - Temporal	0.28 (0.41)	0.28 (0.41)
1 week - Temporal	1.06 (0.70)	0.91 (0.76)
Baseline - Superior	0.09 (0.30)	0.09 (0.30)
1 week - Superior	0.13 (0.34)	0.09 (0.27)
Baseline - Inferior	0.22 (0.41)	0.22 (0.41)
1 week - Inferior	0.68 (0.79)	0.78 (0.96)

11. Primary Outcome

Title	Lens Durability
Description	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).
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Measure Lenses	88	88
Number [Lens tear or nick]	1	0

12. Primary Outcome

Title	Lens Fit Acceptance
Description	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.
Time Frame	Baseline and 1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	3.5 (0.3)	3.4 (0.3)
1 week	3.5 (0.4)	3.3 (0.4)

13. Secondary Outcome

Title	Dryness
Description	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.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
During the Day	82 (18)	74 (23)
End of Day	76 (21)	67 (24)

14. Secondary Outcome

Title	Overall Satisfaction
Description	Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Toric Lens	Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
Measure Participants	44	44
Baseline	87 (13)	80 (16)
1 week	83 (17)	77 (23)

Adverse Events

Arm/Group Title	Stenfilcon A Toric Lens		Etafilcon A Toric Lens
Arm/Group Description	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. stenfilcon A: toric contact lens		Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. etafilcon A: toric contact lens
All Cause Mortality
	Stenfilcon A Toric Lens		Etafilcon A Toric Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stenfilcon A Toric Lens		Etafilcon A Toric Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Stenfilcon A Toric Lens		Etafilcon A Toric Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.