Trial Outcomes & Findings for Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens. (NCT NCT01055132)

Results Overview

Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

After 5 to 9 days of lens wear

Results posted on

2018-06-19

Participant Flow

One subject failed screening, and did not enter group assignment

Participant milestones

Participant milestones
Measure	Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days	Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
Period 1 (5-9 Days) STARTED	36	33
Period 1 (5-9 Days) COMPLETED	35	33
Period 1 (5-9 Days) NOT COMPLETED	1	0
Period 2 (5-9 Days) STARTED	35	33
Period 2 (5-9 Days) COMPLETED	35	32
Period 2 (5-9 Days) NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days	Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
Period 1 (5-9 Days) unsatisfactory lens fitting performance	1	0
Period 2 (5-9 Days) Unsatisfactory lens fitting performance	0	1

Baseline Characteristics

Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=69 Participants All subjects who completed the study.
Age, Continuous	29.1 years STANDARD_DEVIATION 5.27 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: After 5 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study.

Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.

Outcome measures

Outcome measures
Measure	Etafilcon A Toric (Test Lens) n=67 Participants Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	Nelfilcon A Toric (Active Comparator) n=67 Participants An existing, daily disposable toric contact lens; worn 5-9 days
Monocular Visual Acuity on LogMAR Scale	-0.065 logMAR Standard Deviation 0.0777	-0.038 logMAR Standard Deviation 0.1057

PRIMARY outcome

Timeframe: After 5 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study.

Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.

Outcome measures

Outcome measures
Measure	Etafilcon A Toric (Test Lens) n=67 Participants Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	Nelfilcon A Toric (Active Comparator) n=67 Participants An existing, daily disposable toric contact lens; worn 5-9 days
Binocular Visual Acuity on LogMAR Scale	-0.122 LogMAR Standard Deviation 0.0718	-0.108 LogMAR Standard Deviation 0.0766

PRIMARY outcome

Timeframe: After 5 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study.

The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).

Outcome measures

Outcome measures
Measure	Etafilcon A Toric (Test Lens) n=67 Participants Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	Nelfilcon A Toric (Active Comparator) n=67 Participants An existing, daily disposable toric contact lens; worn 5-9 days
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire	56.4 units on a scale Standard Deviation 9.12	44.0 units on a scale Standard Deviation 9.34

PRIMARY outcome

Timeframe: After 5 to 9 days of lens wear

Population: Analysis was conducted on subjects who successfully complete the study.

The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).

Outcome measures

Outcome measures
Measure	Etafilcon A Toric (Test Lens) n=67 Participants Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	Nelfilcon A Toric (Active Comparator) n=67 Participants An existing, daily disposable toric contact lens; worn 5-9 days
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.	52.7 units on a scale Standard Deviation 8.64	44.7 units on a scale Standard Deviation 9.41

Adverse Events

Etafilcon A Toric / Nelfilcon A Toric

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

Ross Franklin

Johnson & Johnson Vision Care

Phone: 1-904-443-1379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications require agreement and written approval from Sponsor.
Publication restrictions are in place

Restriction type: OTHER