CLAN: Contact Lens Adaptation in Neophytes

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02148263
• Collaborator: National Institutes of Health (NIH) (NIH), National Eye Institute (NEI) (NIH)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 64.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Comfort	Device: senofilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Contact Lens Adaptation in Neophytes
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Aug 20, 2019
• Actual Study Completion Date: Sep 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Full-Time Senofilcon A Contact Lens Wear This group will start wearing contact lenses 8 or more hours per day on the first day of wear	Device: senofilcon A; Other Names: Acuvue Oasys
Experimental: Graduated Senofilcon A Contact Lens Wear This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours).	Device: senofilcon A; Other Names: Acuvue Oasys

Outcome Measures

Primary Outcome Measures

1. Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) [2 weeks]

   This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.

Secondary Outcome Measures

1. Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart [2 weeks]

   The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores.

2. Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) [2 Weeks]

   Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability.

3. Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH) [2 Weeks]

   Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume.

4. Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M [2 Weeks]

   Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better.

5. Between-Group Difference in Upper and Lower Eyelid Blepharitis [2 Weeks]

   A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.

6. Between-Group Difference in Corneal Sodium Fluorescein Staining [2 Weeks]

   The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining.

7. Between-Group Difference in Tear Volume as Measured by Schirmer's Test I [2 Weeks]

   Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume.

8. Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS) [2 Weeks]

   End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Has had a completed comprehensive eye exam within the past 6 months

• Able to wear spherical senofilcon A contact lenses

• Able to use Opti-Free PureMoist contact lens solution

Exclusion Criteria:

• Any prior contact lens use

• Topical eye drops within the last two hours of the study visit

• Known systemic health conditions known to alter tear film physiology

• History of severe ocular trauma

• Active ocular infection

• Active ocular inflammation

• Known hypersensitivity to diagnostic eye drops

• Pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• National Institutes of Health (NIH)
• National Eye Institute (NEI)

Investigators

• Principal Investigator: Andrew D Pucker, OD, MS, Ohio State University
• Principal Investigator: Jeffrey J Walline, OD, PhD, Ohio State University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 3, 2020

More Information

Publications

• Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. Review.
• Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. Epub 2006 Jan 31.
• Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027.
• Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
• Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4.
• Sullivan BD, Crews LA, Sönmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
• Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.
• Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7.

• Responsible Party: Andrew Pucker, Senior Research Associate, Ohio State University
• ClinicalTrials.gov Identifier: NCT02148263
• Other Study ID Numbers: 2014H0074; K08EY023264
• First Posted: May 28, 2014
• Last Update Posted: Aug 22, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Andrew Pucker, Senior Research Associate, Ohio State University: Contact Lenses; Neophytes; Contact Lens Adaptation; Randomized

Study Results

Participant Flow

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Period Title: Overall Study
STARTED	12	13
COMPLETED	9	11
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear	Total
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A	Total of all reporting groups
Overall Participants	12	13	25
Age (Count of Participants)
<=18 years	1 8.3%	0 0%	1 4%
Between 18 and 65 years	11 91.7%	13 100%	24 96%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	22.8	24.1	23.45
Sex: Female, Male (Count of Participants)
Female	7 58.3%	4 30.8%	11 44%
Male	5 41.7%	9 69.2%	14 56%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%	13 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
Description	This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Mean (Standard Deviation) [Units on a Scale]	10.8 (8.5)	16.3 (18.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
Description	The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Mean (Standard Deviation) [units on a scale]	0.03 (0.05)	0.01 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
Description	Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Mean (Standard Deviation) [seconds]	11.7 (7.0)	9.8 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.94
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
Description	Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Median (Standard Deviation) [mm]	0.31 (0.09)	0.32 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.96
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
Description	Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Mean (Standard Deviation) [units on a scale]	0.69 (0.37)	0.59 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.14
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Between-Group Difference in Upper and Lower Eyelid Blepharitis
Description	A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Two Weeks (Upper Eyelid)	1.1 (1.3)	1.3 (0.8)
Two Weeks (Lower Eyelid)	0.4 (0.7)	0.8 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments	This is for the upper eyelid evaluation.
Statistical Test of Hypothesis	p-Value	.27
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments	This is for the lower eyelid evaluation.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.58
	Comments
	Method	Fisher Exact
	Comments

7. Secondary Outcome

Title	Between-Group Difference in Corneal Sodium Fluorescein Staining
Description	The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Two Weeks (Extent)	0.0 (0.1)	0.3 (0.4)
Two Weeks (Type)	0.0 (0.0)	0.2 (0.4)
Two Weeks (Depth)	0.0 (0.1)	0.2 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments	Extent
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.50
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments	Type
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.76
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments	Depth
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.50
	Comments
	Method	Fisher Exact
	Comments

8. Secondary Outcome

Title	Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
Description	Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Mean (Standard Deviation) [mm]	15.9 (8.8)	21.2 (12.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
Description	End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear	Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
Measure Participants	9	11
Mean (Standard Deviation) [score on a scale]	89.0 (9.7)	81.8 (18.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full-Time Senofilcon A Contact Lens Wear, Graduated Senofilcon A Contact Lens Wear
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Full-Time Senofilcon A Contact Lens Wear		Graduated Senofilcon A Contact Lens Wear
Arm/Group Description	This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A		This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours). senofilcon A
All Cause Mortality
	Full-Time Senofilcon A Contact Lens Wear		Graduated Senofilcon A Contact Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/11 (0%)
Serious Adverse Events
	Full-Time Senofilcon A Contact Lens Wear		Graduated Senofilcon A Contact Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Full-Time Senofilcon A Contact Lens Wear		Graduated Senofilcon A Contact Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/11 (0%)

Limitations/Caveats

There was a data collection error, which prevented the study from analyzing CLDEQ-8 scores. This study also intended to included conjunctival staining with lissamine green; however, lissamine green was not available during the conduct of this study, so this outcome was not included.

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.