Trial Outcomes & Findings for Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens (NCT NCT01151371)

Results Overview

Contact Lens User Experience (CLUE)TM questionnaire: 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

452 participants

Primary outcome timeframe

After 1 week

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Narafilcon B 4 Weeks lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A 1 Week lenses worn daily on a daily disposable/replacement schedule, for 1 week	Lotrafilcon B 4 Weeks lenses worn daily on a 1-month replacement schedule, for 4 weeks
Overall Study STARTED	149	150	153
Overall Study COMPLETED	144	149	146
Overall Study NOT COMPLETED	5	1	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Narafilcon B 4 Weeks n=149 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A 1 Week n=150 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week	Lotrafilcon B 4 Weeks n=153 Participants lenses worn daily on a 1-month replacement schedule, for 4 weeks	Total n=452 Participants Total of all reporting groups
Age, Continuous	27.9 years STANDARD_DEVIATION 6.4 • n=5 Participants	27.6 years STANDARD_DEVIATION 6.0 • n=7 Participants	28 years STANDARD_DEVIATION 6.2 • n=5 Participants	27.8 years STANDARD_DEVIATION 6.2 • n=4 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	104 Participants n=7 Participants	112 Participants n=5 Participants	328 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	46 Participants n=7 Participants	41 Participants n=5 Participants	124 Participants n=4 Participants
Region of Enrollment United States	149 participants n=5 Participants	150 participants n=7 Participants	153 participants n=5 Participants	452 participants n=4 Participants

PRIMARY outcome

Timeframe: After 1 week

Contact Lens User Experience (CLUE)TM questionnaire: 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.

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Overall Comfort Narafilcon B v. Nelfilcon A	68.32 units on a scale Standard Deviation 22.82 • Interval 8.4 to 21.0	53.75 units on a scale Standard Deviation 23.71

PRIMARY outcome

Timeframe: After 1 Week

Redness scale of 0 to 4, where 0=None, 4=Severe redness

Outcome measures

Outcome measures
Measure	Narafilcon B n=294 eyes lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=296 eyes lenses worn daily on a daily disposable/replacement schedule, for 1 week
Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A	0.53 Units on a scale Standard Deviation 0.50	0.61 Units on a scale Standard Deviation 0.51

PRIMARY outcome

Timeframe: After 4 Weeks

Contact Lens User Experience (CLUE)TM questionnaire: 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.

Outcome measures

Outcome measures
Measure	Narafilcon B n=142 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=143 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B	66.43 units on a scale Standard Deviation 23.37	53.91 units on a scale Standard Deviation 23.72

PRIMARY outcome

Timeframe: After 4 Weeks

Redness scale of 0 to 4, where 0=None, and 4=Severe.

Outcome measures

Outcome measures
Measure	Narafilcon B n=284 eyes lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=286 eyes lenses worn daily on a daily disposable/replacement schedule, for 1 week
Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B	0.44 units on a scale Standard Deviation 0.47	0.68 units on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: After 1 Week

Standard scale of 0 to 3 where 0=None, 3=Severe staining

Outcome measures

Outcome measures
Measure	Narafilcon B n=294 eyes lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=296 eyes lenses worn daily on a daily disposable/replacement schedule, for 1 week
Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A	0.13 units on a scale Standard Deviation 0.36	0.31 units on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: After 1 Week

Contact Lens User Experience (CLUE)TM questionnaire: 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.

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A	64.05 units on a scale Standard Deviation 22.35	60.76 units on a scale Standard Deviation 22.03

SECONDARY outcome

Timeframe: After 1 Week

Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A	3.69 units on a scale Standard Error 0.11	2.81 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: After 1 Week

Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A	4.10 units on a scale Standard Error 0.13	3.92 units on a scale Standard Error 010

SECONDARY outcome

Timeframe: After 4 Weeks

Scale of 0 to 3, where 0=none and 3=severe staining.

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B	0.14 units on a scale Standard Deviation 0.41	0.34 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: After 4 Weeks

Contact Lens User Experience (CLUE)TM questionnaire: 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.

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B	62.58 units on a scale Standard Deviation 22.79	55.50 units on a scale Standard Deviation 22.47

SECONDARY outcome

Timeframe: After 4 Weeks

Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B	3.55 units on a scale Standard Error 0.11	2.95 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: After 4 Weeks

Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.

Outcome measures

Outcome measures
Measure	Narafilcon B n=147 Participants lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Nelfilcon A n=148 Participants lenses worn daily on a daily disposable/replacement schedule, for 1 week
Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B	4.25 units on a scale Standard Error 0.10	3.79 units on a scale Standard Error 0.09

Adverse Events

Narafilcon B 4 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A 1 Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B 4 Weeks

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

Kathy Lorenz-Osborn, OD

Vistakon

Phone: +1 904 443-1032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must provide written approval for any publication.
Publication restrictions are in place

Restriction type: OTHER