Comparison of Two Toric Contact Lenses on Current Toric Wearers

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00639379
• Collaborator: (none)
• Enrollment: 89
• Locations: 7
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 12.7
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: senofilcon A toric; Device: alphafilcon A toric	N/A

Detailed Description

Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:

Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: senofilcon A senofilcon A toric daily wear contact lenses	Device: senofilcon A toric; silicone hydrogel toric lens, 2 wk replacement, daily wear; Other Names: ACUVUE OASYS
Active Comparator: alphafilcon A alphafilcon A toric daily wear contact lenses	Device: alphafilcon A toric; hydrogel toric lens, 2 wk replacement, daily wear; Other Names: SofLens Toric

Outcome Measures

Primary Outcome Measures

1. Lens Orientation Within 5 Degrees [1 minute after insertion]

   Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

2. Lens Stability [10-15 minutes after insertion]

   Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.

3. Subjective Lens Comfort [1 and 2 weeks]

   A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.

4. Subjective Vision [1 and 2 weeks]

   A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.

5. Overall Corneal Staining [after 2 weeks use]

   Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).

2. Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.

3. Be a currently successful wearer for at least 3 months of B&L SofLens 66 Toric hydrogel lenses.

4. Be able and willing to adhere to the instructions set forth in the protocol.

5. Agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.

6. Have a distance spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form).

7. Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.

8. Be in good general health, based on his/her knowledge.

9. Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.

Exclusion Criteria:

1. Presbyopic or has the need for a near add for reading.

2. Previous refractive surgery; current or previous orthokeratology treatment.

3. Aphakia, keratoconus or a highly irregular cornea.

4. The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).

5. A known history of corneal hypoesthesia (reduced corneal sensitivity.)

6. Anterior uveitis or iritis (past or present).

7. A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.

8. Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.

9. Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Pterygium or corneal scars within the visual axis

• Neovascularization >1mm in from the limbus

• History of giant papillary conjunctivitis (GPC) worse than Grade 2

• Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis

1. Current pregnancy or lactation (to the best of the subject's knowledge).

2. Actively participating in another clinical study at any time during this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ted Brink and Associates	Jacksonville	Florida	United States	32256
2	Eola Eyes	Orlando	Florida	United States	32801
3	Clayton Eye Center	Morrow	Georgia	United States	30260
4	The Koetting Associates Inc.	St Louis	Missouri	United States	63144
5	Southern Eyes	Concord	North Carolina	United States	28025
6	Western Reserve Vision Care	Beachwood	Ohio	United States	44122
7	Primary Eyecare Group, P.C.	Brentwood	Tennessee	United States	37027

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00639379
• Other Study ID Numbers: CR-0802
• First Posted: Mar 20, 2008
• Last Update Posted: May 21, 2015
• Last Verified: May 1, 2015

• Keywords provided by Johnson & Johnson Vision Care, Inc.: toric contact lenses; vision; comfort; toric fit characteristics; slit lamp findings
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Senofilcon A Toric / Alphafilcon A Toric	Alphafilcon A Toric / Senofilcon A Toric
Arm/Group Description	senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.	alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
Period Title: Period 1 - 2 Weeks
STARTED	44	45
COMPLETED	39	45
NOT COMPLETED	5	0
Period Title: Period 1 - 2 Weeks
STARTED	39	45
COMPLETED	39	45
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Total Completed Participants
Arm/Group Description
Overall Participants	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (8.05)
Sex: Female, Male (Count of Participants)
Female	53 63.1%
Male	31 36.9%

Outcome Measures

1. Primary Outcome

Title	Lens Orientation Within 5 Degrees
Description	Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.
Time Frame	1 minute after insertion

Outcome Measure Data

Analysis Population Description

Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.

Arm/Group Title	Senofilcon A Toric	Alphafilcon A Toric
Arm/Group Description
Measure Participants	84	84
Number [Eyes]	128	128

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A Toric, Alphafilcon A Toric
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin is 0.65
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.967
	Confidence Interval	(2-Sided) 98.98%; 0.436 to 0.967
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is senofilcon A toric / alphafilcon A toric.

2. Primary Outcome

Title	Lens Stability
Description	Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Time Frame	10-15 minutes after insertion

Outcome Measure Data

Analysis Population Description

Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.

Arm/Group Title	Senofilcon A Toric	Alphafilcon A Toric
Arm/Group Description
Measure Participants	84	84
Number [Eyes]	144	138

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A Toric, Alphafilcon A Toric
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.65
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.416
	Confidence Interval	(2-Sided) 98.98%; 0.680 to 1.416
	Parameter Dispersion	Type: Value:
	Estimation Comments	Odds ratio is senofilcon A toric / alphafilcon A toric.

3. Primary Outcome

Title	Subjective Lens Comfort
Description	A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.
Time Frame	1 and 2 weeks

Outcome Measure Data

Analysis Population Description

Subjects that completed the study were analyzed.

Arm/Group Title	Senofilcon A Toric	Alphafilcon A Toric
Arm/Group Description
Measure Participants	84	84
Least Squares Mean (Standard Error) [Units on a scale]	0.08125 (0.08771)	-0.1055 (0.08771)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A Toric, Alphafilcon A Toric
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = -0.4
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1868
	Confidence Interval	(2-Sided) 98.98%; -0.0517 to 0.1868
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0921
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.

4. Primary Outcome

Title	Subjective Vision
Description	A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.
Time Frame	1 and 2 weeks

Outcome Measure Data

Analysis Population Description

Subjects that completed the study were analyzed.

Arm/Group Title	Senofilcon A Toric	Alphafilcon A Toric
Arm/Group Description
Measure Participants	84	84
Least Squares Mean (Standard Error) [Units on a scale]	-0.0420 (0.08885)	-0.0302 (0.08885)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A Toric, Alphafilcon A Toric
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = -0.4
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01185
	Confidence Interval	(2-Sided) 98.98%; -0.2337 to -0.01185
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08566
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.

5. Primary Outcome

Title	Overall Corneal Staining
Description	Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time Frame	after 2 weeks use

Outcome Measure Data

Analysis Population Description

Subjects that completed the study were analyzed.

Arm/Group Title	Senofilcon A Toric	Alphafilcon A Toric
Arm/Group Description
Measure Participants	84	84
Least Squares Mean (Standard Error) [Units on a scale]	0.04921 (0.01174)	0.06188 (0.01176)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A Toric, Alphafilcon A Toric
	Comments	Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.5
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01267
	Confidence Interval	(2-Sided) 98.98%; -0.01267 to 0.01986
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.01265
	Estimation Comments	The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.

Adverse Events

Arm/Group Title	Senofilcon A Toric / Alphafilcon A Toric		Alphafilcon A Toric / Senofilcon A Toric
Arm/Group Description	senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.		alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
All Cause Mortality
	Senofilcon A Toric / Alphafilcon A Toric		Alphafilcon A Toric / Senofilcon A Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon A Toric / Alphafilcon A Toric		Alphafilcon A Toric / Senofilcon A Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A Toric / Alphafilcon A Toric		Alphafilcon A Toric / Senofilcon A Toric
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.