Trial Outcomes & Findings for Assessment of Daily Disposable Silicone Hydrogel Lens Wear (NCT NCT01093625)

NCT ID: NCT01093625

Last Updated: 2018-06-19

Results Overview

Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 157 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2018-06-19

Participant Flow

There were 157 subjects consented to participate in this study. Fifty-nine (59) subjects were determined to be ineligible. This allotted forty-nine (49) subjects randomly to each study arm for a total of 98 subjects enrolled.

Of the 59 identified as ineligible prior to group assignment, the majority were due to having a preexisting astigmatism.

Participant milestones

Measure	Investigational Silicone Hydrogel Contact Lens Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Baseline and Dispensed STARTED	49	49
Baseline and Dispensed COMPLETED	47	49
Baseline and Dispensed NOT COMPLETED	2	0
2-Week Visit STARTED	47	49
2-Week Visit COMPLETED	46	49
2-Week Visit NOT COMPLETED	1	0
1-Month Visit STARTED	46	49
1-Month Visit COMPLETED	44	49
1-Month Visit NOT COMPLETED	2	0
3-Month Visit STARTED	44	49
3-Month Visit COMPLETED	42	49
3-Month Visit NOT COMPLETED	2	0
6-Month Visit STARTED	42	49
6-Month Visit COMPLETED	34	40
6-Month Visit NOT COMPLETED	8	9
1-Year Visit STARTED	34	40
1-Year Visit COMPLETED	29	37
1-Year Visit NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Investigational Silicone Hydrogel Contact Lens Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Baseline and Dispensed Withdrawal by Subject	2	0
2-Week Visit Withdrawal by Subject	1	0
1-Month Visit Lost to Follow-up	2	0
3-Month Visit Lost to Follow-up	2	0
6-Month Visit Withdrawal by Subject	6	7
6-Month Visit Lost to Follow-up	2	2
1-Year Visit Lost to Follow-up	5	3

Baseline Characteristics

Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Baseline characteristics by cohort

Measure	Investigational Silicone Hydrogel Contact Lens n=49 Participants Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.	Spectacles n=49 Participants Subjects are randomized to this Control Group.	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=93 Participants	49 Participants n=4 Participants	98 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	22.57 years STANDARD_DEVIATION 6.67 • n=93 Participants	23.31 years STANDARD_DEVIATION 6.08 • n=4 Participants	22.94 years STANDARD_DEVIATION 6.36 • n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	21 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	28 Participants n=4 Participants	49 Participants n=27 Participants
Region of Enrollment United States	49 participants n=93 Participants	49 participants n=4 Participants	98 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles n=37 Participants Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Papillary Conjunctivitis	0.98 units on a scale Interval 0.83 to 1.14	0.47 units on a scale Interval 0.32 to 0.61

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles n=37 Participants Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Conjunctival Hyperemia	0.26 units on a scale Interval 0.13 to 0.39	0.28 units on a scale Interval 0.17 to 0.39

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles n=37 Participants Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Limbal Hyperemia	0.56 units on a scale Interval 0.45 to 0.67	0.30 units on a scale Interval 0.19 to 0.4

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles n=37 Participants Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Corneal Staining	0.26 Efron Scale (0.1 Unit increments) Interval 0.21 to 0.3	0.12 Efron Scale (0.1 Unit increments) Interval 0.07 to 0.16

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles n=37 Participants Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Conjunctival Staining	1.41 units on a scale Interval 1.24 to 1.58	0.39 units on a scale Interval 0.24 to 0.55

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles n=37 Participants Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Corneal Neovascularization	0.30 units on a scale Interval 0.25 to 0.34	0.09 units on a scale Interval 0.05 to 0.13

PRIMARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.

The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire Comparison of First Visit - Last Visit	-4.97 units on a scale Interval -12.26 to 2.32	—
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire Comparison of 6-Month Visit - Last Visit	0.62 units on a scale Interval -7.0 to 8.24	—

SECONDARY outcome

Timeframe: 1 Year

Population: Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.

Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.

Outcome measures

Measure	Investigational Silicone Hydrogel Contact Lens n=29 Participants Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Spectacles Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Comfortable Wearing Time	10.25 Hours Interval 9.79 to 10.72	—

Adverse Events

Investigational Silicone Hydrogel Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spectacles

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

Katherine E. Osborn

Vistakon

Email: clinicalstudies@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication required agreement and written authorization from the Sponsor
• Publication restrictions are in place

Restriction type: OTHER