Trial Outcomes & Findings for Contact Lens Adaptation in Neophytes (NCT NCT02148263)

NCT ID: NCT02148263

Last Updated: 2022-09-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2022-09-29

Participant Flow

Participant milestones

Measure	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 senofilcon A	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). senofilcon A
Overall Study STARTED	12	13
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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 senofilcon A	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). senofilcon A
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Full-Time Senofilcon A Contact Lens Wear n=12 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=13 Participants 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 n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=12 Participants	0 Participants n=13 Participants	1 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=12 Participants	13 Participants n=13 Participants	24 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=25 Participants
Age, Continuous	22.8 Years n=12 Participants	24.1 Years n=13 Participants	23.45 Years n=25 Participants
Sex: Female, Male Female	7 Participants n=12 Participants	4 Participants n=13 Participants	11 Participants n=25 Participants
Sex: Female, Male Male	5 Participants n=12 Participants	9 Participants n=13 Participants	14 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 Participants n=12 Participants	13 Participants n=13 Participants	25 Participants n=25 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)	10.8 Units on a Scale Standard Deviation 8.5	16.3 Units on a Scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart	0.03 units on a scale Standard Deviation 0.05	0.01 units on a scale Standard Deviation 0.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)	11.7 seconds Standard Deviation 7.0	9.8 seconds Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)	0.31 mm Standard Deviation 0.09	0.32 mm Standard Deviation 0.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M	0.69 units on a scale Standard Deviation 0.37	0.59 units on a scale Standard Deviation 0.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Upper and Lower Eyelid Blepharitis Two Weeks (Upper Eyelid)	1.1 units on a scale Standard Deviation 1.3	1.3 units on a scale Standard Deviation 0.8
Between-Group Difference in Upper and Lower Eyelid Blepharitis Two Weeks (Lower Eyelid)	0.4 units on a scale Standard Deviation 0.7	0.8 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Corneal Sodium Fluorescein Staining Two Weeks (Extent)	0.0 units on a scale Standard Deviation 0.1	0.3 units on a scale Standard Deviation 0.4
Between-Group Difference in Corneal Sodium Fluorescein Staining Two Weeks (Type)	0.0 units on a scale Standard Deviation 0.0	0.2 units on a scale Standard Deviation 0.4
Between-Group Difference in Corneal Sodium Fluorescein Staining Two Weeks (Depth)	0.0 units on a scale Standard Deviation 0.1	0.2 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in Tear Volume as Measured by Schirmer's Test I	15.9 mm Standard Deviation 8.8	21.2 mm Standard Deviation 12.5

SECONDARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Measure	Full-Time Senofilcon A Contact Lens Wear n=9 Participants This group will start wearing contact lenses 8 or more hours per day on the first day of wear senofilcon A	Graduated Senofilcon A Contact Lens Wear n=11 Participants 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
Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)	89.0 score on a scale Standard Deviation 9.7	81.8 score on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: 2-Weeks

Population: The electronic data capture system did not record these data correctly, so we could not analyze it. Therefore, data from the CLDEQ-8 are not valid.

Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort.

Outcome measures

Outcome data not reported

Adverse Events

Full-Time Senofilcon A Contact Lens Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Graduated Senofilcon A Contact Lens Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Pucker

The University of Alabama at Birmingham

Phone: 920-579-2900

Email: apucker@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place