Trial Outcomes & Findings for Comparative Study of Two Marketed 1-day Soft Contact Lenses (NCT NCT01464255)

NCT ID: NCT01464255

Last Updated: 2014-08-19

Results Overview

The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 71 participants
• Primary outcome timeframe: Baseline and 7 days from baseline visit
• Results posted on: 2014-08-19

Participant Flow

A total of 71 subjects were recruited for the study, with 21 subjects being disqualified at the initial screening for a total of 50 subjects started.

Fifty subjects started. Forty-nine subjects completed the study. One subject was disqualified after one week of wear of the control lens (ocufilcon B) during the 1st week of the study due to unresolved corneal staining.

Participant milestones

Measure	Ocufilcon D Then Ocufilcon B Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.	Ocufulcon B Then Ocufilcon D Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Ocufilcon D Then Ocufilcon B Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.	Ocufulcon B Then Ocufilcon D Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
Overall Study unresolve corneal staining	0	1

Baseline Characteristics

Comparative Study of Two Marketed 1-day Soft Contact Lenses

Baseline characteristics by cohort

Measure	Ocufilcon D Then Ocufilcon B n=25 Participants Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.	Ocufilcon B Then Ocufilcon D n=24 Participants Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7 days from baseline visit

Population: Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2

The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Lens Fit - Decentration After Insertion Horizontal	0.12 mm Standard Deviation 0.29	0.07 mm Standard Deviation 0.30
Lens Fit - Decentration After Insertion Vertical	-0.11 mm Standard Deviation 0.47	-0.15 mm Standard Deviation 0.48

PRIMARY outcome

Timeframe: 7 days and 14 days from baseline visit

Population: Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2

The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Lens Fit - Decentration at One Week Horizontal	0.14 mm Standard Deviation 0.36	0.09 mm Standard Deviation 0.37
Lens Fit - Decentration at One Week Vertical	-0.08 mm Standard Deviation 0.39	-0.18 mm Standard Deviation 0.51

PRIMARY outcome

Timeframe: Baseline and 7 days from baseline visit

Population: Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2

The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Lens Fit - Tightness After Insertion	50.0 percentage of tightness Standard Deviation 14.1	52.4 percentage of tightness Standard Deviation 15.7

PRIMARY outcome

Timeframe: 7 days and 14 days from baseline visit

Population: Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2

The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Lens Fit - Tightness at One Week	42.4 percentage of tightness Standard Deviation 12.9	46 percentage of tightness Standard Deviation 13.7

PRIMARY outcome

Timeframe: Baseline and 7 days from baseline visit

Population: Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2

The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Lens Fit - Post-Blink Lens Movement After Insertion	0.29 mm Standard Deviation 0.28	0.3 mm Standard Deviation 0.32

PRIMARY outcome

Timeframe: 7 days and 14 days from baseline visit

Population: Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2

The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Lens Fit - Post-Blink Lens Movement Prior to Removal	0.38 mm Standard Deviation 0.32	0.48 mm Standard Deviation 0.41

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Preference - Comfort After Insertion Strongly Prefer Test Lenses	43 percentage of participants	—
Overall Preference - Comfort After Insertion Slightly Prefer Test Lenses	21 percentage of participants	—
Overall Preference - Comfort After Insertion No Preference	18 percentage of participants	—
Overall Preference - Comfort After Insertion Slightly Prefer Control Lenses	16 percentage of participants	—
Overall Preference - Comfort After Insertion Strongly Prefer Control Lenses	2 percentage of participants	—

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Preference - Comfort Before Removal No Preference	18 percentage of participants	—
Overall Preference - Comfort Before Removal Strongly Prefer Test Lenses	29 percentage of participants	—
Overall Preference - Comfort Before Removal Slightly Prefer Test Lenses	29 percentage of participants	—
Overall Preference - Comfort Before Removal Slightly Prefer Control Lenses	20 percentage of participants	—
Overall Preference - Comfort Before Removal Strongly Prefer Control Lenses	4 percentage of participants	—

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Preference - Dryness After Insertion Slightly Prefer Test Lenses	12 percentage of participants	—
Overall Preference - Dryness After Insertion Slightly Prefer Control Lenses	10 percentage of participants	—
Overall Preference - Dryness After Insertion Strongly Prefer Test Lenses	23 percentage of participants	—
Overall Preference - Dryness After Insertion No Preference	55 percentage of participants	—
Overall Preference - Dryness After Insertion Strongly Prefer Control Lenses	0 percentage of participants	—

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Preference - Dryness Before Removal No Preference	25 percentage of participants	—
Overall Preference - Dryness Before Removal Strongly Prefer Test Lenses	33 percentage of participants	—
Overall Preference - Dryness Before Removal Slightly Prefer Test Lenses	22 percentage of participants	—
Overall Preference - Dryness Before Removal Slightly Prefer Control Lenses	18 percentage of participants	—
Overall Preference - Dryness Before Removal Strongly Prefer Control Lenses	2 percentage of participants	—

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Preference - Handling, Inserting Slightly Prefer Test Lenses	23 percentage of participants	—
Overall Preference - Handling, Inserting Strongly Prefer Test Lenses	18 percentage of participants	—
Overall Preference - Handling, Inserting No Preference	47 percentage of participants	—
Overall Preference - Handling, Inserting Slightly Prefer Control Lenses	8 percentage of participants	—
Overall Preference - Handling, Inserting Strongly Prefer Control Lenses	4 percentage of participants	—

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Preference - Handling, Removing No Preference	74 percentage of participants	—
Overall Preference - Handling, Removing Strongly Prefer Control Lenses	0 percentage of participants	—
Overall Preference - Handling, Removing Strongly Prefer Test Lenses	8 percentage of participants	—
Overall Preference - Handling, Removing Slightly Prefer Test Lenses	16 percentage of participants	—
Overall Preference - Handling, Removing Slightly Prefer Control Lenses	2 percentage of participants	—

SECONDARY outcome

Timeframe: 14 days from baseline visit

Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.

Outcome measures

Measure	Ocufilcon D Then Ocufilcon B n=49 Participants Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Ocufilcon B Then Ocufilcon D Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Overall Lens Pair Preference No Preference	2 percentage of participants	—
Overall Lens Pair Preference Strongly Prefer Test Lenses	43 percentage of participants	—
Overall Lens Pair Preference Slightly Prefer Test Lenses	22 percentage of participants	—
Overall Lens Pair Preference Slightly Prefer Control Lenses	29 percentage of participants	—
Overall Lens Pair Preference Strongly Prefer Control Lenses	4 percentage of participants	—

Adverse Events

Ocufilcon D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ocufilcon B

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

Thao N Yeh, O.D.

Clinical Research Center, University of California, Berkeley, School of Optometry

Phone: (510) 642-9649

Email: thaoyeh@berkeley.edu

Results disclosure agreements

• Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor. This restriction will apply for a period of five years from completion of the study.
• Publication restrictions are in place

Restriction type: OTHER