Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01180998
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 200
• Locations: 18
• Arms: 3
• Actual Duration (Months): 4
• Patients Per Site: 11.1
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Spherical contact lens users Habitual spherical contact lens (non-toric lens) users tried one of two toric lenses in a daily wear modality.	Device: Senofilcon A Toric (AOfA); Soft toric contact lenses for astigmatism; Device: Etafilcon A Toric (1DAMfA); Soft toric contact lenses for astigmatism
Other: Contact lens drop-outs Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, tried one of two toric lenses in a daily wear modality.	Device: Senofilcon A Toric (AOfA); Soft toric contact lenses for astigmatism; Device: Etafilcon A Toric (1DAMfA); Soft toric contact lenses for astigmatism
Other: Habitual Correction with Spectacles (Neophytes) Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses tried one of two toric lenses in a daily wear modality.	Device: Senofilcon A Toric (AOfA); Soft toric contact lenses for astigmatism; Device: Etafilcon A Toric (1DAMfA); Soft toric contact lenses for astigmatism

Outcome Measures

Primary Outcome Measures

1. Overall Success in Fitting With a Toric Contact Lens [4 weeks]

   Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.

2. Distance Visual Acuity [after 1 week of toric contact lens wear]

   Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.

3. Distance Visual Acuity (VA) [after 4 weeks of toric contact lens wear]

   Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

1. One of the following:

2. Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)

3. Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)

4. Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.

5. Between 16 and 60 years of age.

6. Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).

7. Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)

8. Refractive astigmatism between -0.75D and -3.00D in both eyes.

9. Have best corrected VA of 6/9 (20/30) or better in each eye.

10. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

11. No amblyopia.

12. No evidence of lid abnormality or infection.

13. No conjunctival abnormality or infection.

14. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).

15. No other active ocular disease.

16. Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only)

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

1. Requires concurrent ocular medication.

2. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.

3. Corneal staining Grade 3 in more than two regions.

4. Extended wear in the last 3 months.

5. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.

6. Abnormal lachrymal secretions.

7. Pre-existing ocular irritation that would preclude contact lens fitting.

8. Keratoconus or other corneal irregularity.

9. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.

10. Has diabetes.

11. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

12. Pregnancy, lactating, or planning a pregnancy at the time of enrollment.

13. Participation in any concurrent clinical trial or in last 60 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Reading	Berkshire	United Kingdom
2		Marlow	Bucks	United Kingdom
3		Broadstone	Dorset	United Kingdom
4		Portchester	Hampshire	United Kingdom
5		Southsea	Hampshire	United Kingdom
6		St. Albans	Herts	United Kingdom
7		Shanklin	Isle Of Wight	United Kingdom
8		Rawtenstall	Lancashire	United Kingdom
9		Hendon	London	United Kingdom
10		Pinner	Middlesex	United Kingdom
11		Teddington	Middlesex	United Kingdom
12		Uxbridge	Middlesex	United Kingdom
13		Cardiff	South Glamorgan	United Kingdom
14		Croydon	Surrey	United Kingdom
15		Coventry	West Midlands	United Kingdom
16		Birmingham		United Kingdom
17		Bristol		United Kingdom
18		Sheffield		United Kingdom

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Visioncare Research Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01180998
• Other Study ID Numbers: CR-201004
• First Posted: Aug 13, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Recruitment Details	Subjects were recruited and randomized to one of two parallel arms. Three categories of subjects were recruited: spherical soft lens wearers, CL drop-outs, neophytes.
Pre-assignment Detail	The data from 10 subjects was disqualified from the analysis due to subjects' ineligibility being determined after enrollment.

Arm/Group Title	Spherical Contact Lens Users	Contact Lens Drop-outs	Habitual Correction With Spectacles (Neophytes)
Arm/Group Description	Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.	Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.	Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Period Title: Overall Study
STARTED	67	72	61
COMPLETED	63	68	51
NOT COMPLETED	4	4	10

Baseline Characteristics

Arm/Group Title	Spherical Contact Lens Users	Contact Lens Drop-outs	Habitual Correction With Spectacles (Neophytes)	Total
Arm/Group Description	Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.	Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.	Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.	Total of all reporting groups
Overall Participants	67	72	61	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.6 (11.8)	39.2 (10.0)	32.4 (12.3)	36.3 (11.6)
Sex: Female, Male (Count of Participants)
Female	20 29.9%	18 25%	33 54.1%	71 35.5%
Male	47 70.1%	54 75%	28 45.9%	129 64.5%
Region of Enrollment (participants) [Number]
United Kingdom	67 100%	72 100%	61 100%	200 100%

Outcome Measures

1. Primary Outcome

Title	Overall Success in Fitting With a Toric Contact Lens
Description	Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.

Arm/Group Title	Spherical Contact Lens Users	Contact Lens Drop-outs	Habitual Correction With Spectacles (Neophytes)
Arm/Group Description	Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.	Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.	Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Measure Participants	66	70	56
Number (95% Confidence Interval) [percentage of participants]	80 119.4%	74 102.8%	70 114.8%

2. Primary Outcome

Title	Distance Visual Acuity
Description	Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Time Frame	after 1 week of toric contact lens wear

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.

Arm/Group Title	Spherical Contact Lens Users	Contact Lens Drop-outs	Habitual Correction With Spectacles (Neophytes)
Arm/Group Description	Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.	Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.	Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Measure Participants	67	72	61
Measure eyes	128	136	102
1DAMfa Lens	-0.03 (0.01)	0.01 (0.01)	0.01 (0.01)
AofA Lens	-0.01 (0.01)	0.05 (0.02)	0.02 (0.02)
Total Monocular VA	-0.02 (0.01)	0.02 (0.01)	0.02 (0.01)

3. Primary Outcome

Title	Distance Visual Acuity (VA)
Description	Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Time Frame	after 4 weeks of toric contact lens wear

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.

Arm/Group Title	Spherical Contact Lens Users	Contact Lens Drop-outs	Habitual Correction With Spectacles (Neophytes)
Arm/Group Description	Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.	Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.	Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Measure Participants	63	68	51
Measure eyes	124	132	94
1DAMfa Lens	-0.03 (0.01)	0.01 (0.01)	0.01 (0.01)
AOfA Lens	0.01 (0.01)	0.04 (0.02)	0.02 (0.02)
Total Monocular VA	-0.02 (0.01)	0.02 (0.01)	0.00 (0.01)

Adverse Events

Arm/Group Title	Spherical Contact Lens Users		Contact Lens Drop-outs		Habitual Correction With Spectacles (Neophytes)
Arm/Group Description	Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.		Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.		Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
All Cause Mortality
	Spherical Contact Lens Users		Contact Lens Drop-outs		Habitual Correction With Spectacles (Neophytes)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Spherical Contact Lens Users		Contact Lens Drop-outs		Habitual Correction With Spectacles (Neophytes)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/72 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Spherical Contact Lens Users		Contact Lens Drop-outs		Habitual Correction With Spectacles (Neophytes)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/72 (0%)		0/61 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication required agreement and written authorization from the Sponsor.