Trial Outcomes & Findings for Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population. (NCT NCT00708032)

NCT ID: NCT00708032

Last Updated: 2019-12-10

Results Overview

Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-12-10

Participant Flow

There were 74 subjects enrolled into the study, 38 into the TruEye group and 36 in the spectacle group. Forty-eight subjects completed the study.

Participant milestones

Measure	Spectacles spectacles worn daily for 12 months	Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months
Overall Study STARTED	36	38
Overall Study COMPLETED	26	22
Overall Study NOT COMPLETED	10	16

Reasons for withdrawal

Measure	Spectacles spectacles worn daily for 12 months	Narafilcon A Lenses narafilcon A soft contact lenses worn as daily disposable for 12 months
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	2
Overall Study Pregnancy	0	1
Overall Study Poor vision	0	6
Overall Study Visit out of range at month 12	4	1
Overall Study Did not meet protocol criteria	1	2
Overall Study Protocol Violation	4	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.

Baseline characteristics by cohort

Measure	Spectacles n=36 Participants spectacles worn daily for 12 months	Narafilcon A Lenses n=38 Participants narafilcon A soft contact lenses worn as daily disposable for 12 months	Total n=74 Participants Total of all reporting groups
Age, Continuous	26.5 years STANDARD_DEVIATION 8.1 • n=5 Participants	26.5 years STANDARD_DEVIATION 7.4 • n=7 Participants	26.5 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United Kingdom	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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

Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.

Outcome measures

Measure	Narafilcon A Lenses n=22 Participants narafilcon A soft contact lenses worn as daily disposable for 12 months	Spectacles n=26 Participants habitual spectacles worn daily for 12 months
Papillary Conjunctivitis	1.22 units on a scale Standard Deviation 0.21	1.04 units on a scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: at 12 months

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

Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.

Outcome measures

Measure	Narafilcon A Lenses n=22 Participants narafilcon A soft contact lenses worn as daily disposable for 12 months	Spectacles n=26 Participants habitual spectacles worn daily for 12 months
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Conjunctival Hyperemia	1.09 units on a scale Standard Deviation 0.22	1.00 units on a scale Standard Deviation 0.22
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Limbal Hyperemia	0.89 units on a scale Standard Deviation 0.25	0.80 units on a scale Standard Deviation 0.24
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Corneal Vascularization	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Microcysts	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Oedema	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Corneal Staining	0.33 units on a scale Standard Deviation 0.32	0.25 units on a scale Standard Deviation 0.27
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. Conjunctival Staining	0.83 units on a scale Standard Deviation 0.40	0.22 units on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: at 12 months

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

Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.

Outcome measures

Measure	Narafilcon A Lenses n=22 Participants narafilcon A soft contact lenses worn as daily disposable for 12 months	Spectacles n=26 Participants habitual spectacles worn daily for 12 months
Visual Acuity After 12 Months of Wear High Contrast	-0.05 logMar Standard Deviation 0.08	-0.11 logMar Standard Deviation 0.06
Visual Acuity After 12 Months of Wear Low Contrast	0.29 logMar Standard Deviation 0.11	0.18 logMar Standard Deviation 0.07

SECONDARY outcome

Timeframe: at 12 months

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

subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort

Outcome measures

Measure	Narafilcon A Lenses n=22 Participants narafilcon A soft contact lenses worn as daily disposable for 12 months	Spectacles n=26 Participants habitual spectacles worn daily for 12 months
Subjective Overall Comfort After 12 Months of Daily Wear	87.8 units on a scale Standard Deviation 10.0	82.2 units on a scale Standard Deviation 15.1

SECONDARY outcome

Timeframe: at 12 months

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

subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision

Outcome measures

Measure	Narafilcon A Lenses n=22 Participants narafilcon A soft contact lenses worn as daily disposable for 12 months	Spectacles n=26 Participants habitual spectacles worn daily for 12 months
Subjective Overall Vision After 12 Months of Daily Wear	88.7 units on a scale Standard Deviation 11.5	82.5 units on a scale Standard Deviation 15.1

Adverse Events

Spectacles

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Narafilcon A Lenses

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Spectacles n=36 participants at risk spectacles worn daily for 12 months	Narafilcon A Lenses n=38 participants at risk narafilcon A soft contact lenses worn as daily disposable for 12 months
Eye disorders Non-signficant Corneal Event	13.9% 5/36 • Number of events 27 • Throughout the entire duration of the sutdy. Approximately 12 month.	10.5% 4/38 • Number of events 7 • Throughout the entire duration of the sutdy. Approximately 12 month.

Additional Information

Kathy Osborn, OD

Johnson & Johnson Vision Care, Inc.

Phone: +1 904 443-1032

Email: clinicalstudies@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication requires agreement and written consent from the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER