Comparative Study of Two Marketed 1-day Soft Contact Lenses

Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01464255

Enrollment

Registered

2011-11-03

Start date

2011-08-31

Completion date

2011-11-30

Last updated

2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

contact lenses

Brief summary

This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.

Detailed description

This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.

Interventions

DEVICEocufilcon 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.

DEVICEocufilcon B

Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Has had a self reported oculo-visual examination in the last two years. * Is able to wear the study lenses for at least eight hours a day, seven days a week * Aged 18-40 years and has full legal capacity as a volunteer * Has a distance contact lens prescription from -0.25 and -6.00D inclusive * Has spectacle astigmatism of \< 1.00D in each eye * Baseline vision of 20/20 best-corrected in each eye. * Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye * Has read and understood the consent form and willing to sign consent form * Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

Exclusion criteria

* Currently wears contact lenses on an extended wear basis. * Not a current or past wearer of the ocufilcon B 52% 1-day lenses. * Has undergone anterior ocular surgery * Is aphakic * Has never worn contact lenses before * Has any systemic disease which clinically contraindicates contact lenses * Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye) * Use of systemic or topical medications that will affect ocular health or visual performance * Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3 * Not possible to achieve a satisfactory fit with the lens design used in the study * Has keratoconus or other corneal irregularity * Participating in another eye-related clinical trial * Pregnant, lactating or planning a pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Lens Fit - Decentration After Insertion	Baseline and 7 days from baseline visit	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).
Lens Fit - Decentration at One Week	7 days and 14 days from baseline visit	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).
Lens Fit - Tightness After Insertion	Baseline and 7 days from baseline visit	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 ).
Lens Fit - Tightness at One Week	7 days and 14 days from baseline visit	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 ).
Lens Fit - Post-Blink Lens Movement After Insertion	Baseline and 7 days from baseline visit	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).
Lens Fit - Post-Blink Lens Movement Prior to Removal	7 days and 14 days from baseline visit	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).

Secondary

Measure	Time frame	Description
Overall Preference - Comfort After Insertion	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.
Overall Lens Pair Preference	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.
Overall Preference - Comfort Before Removal	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.
Overall Preference - Dryness After Insertion	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.
Overall Preference - Dryness Before Removal	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.
Overall Preference - Handling, Inserting	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.
Overall Preference - Handling, Removing	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	25
Ocufilcon 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.	24
Total	49

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	unresolve corneal staining	0	1

Baseline characteristics

Characteristic	Ocufilcon D Then Ocufilcon B	Ocufilcon B Then Ocufilcon D	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	25 Participants	24 Participants	49 Participants
Region of Enrollment United States	25 participants	24 participants	49 participants
Sex: Female, Male Female	17 Participants	15 Participants	32 Participants
Sex: Female, Male Male	8 Participants	9 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 50	0 / 50
serious Total, serious adverse events	0 / 50	0 / 50

Outcome results

Primary

Lens Fit - Decentration After Insertion

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).

Time frame: Baseline and 7 days from baseline visit

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ocufilcon D Then Ocufilcon B	Lens Fit - Decentration After Insertion	Horizontal	0.12 mm	Standard Deviation 0.29
Ocufilcon D Then Ocufilcon B	Lens Fit - Decentration After Insertion	Vertical	-0.11 mm	Standard Deviation 0.47
Ocufilcon B Then Ocufilcon D	Lens Fit - Decentration After Insertion	Horizontal	0.07 mm	Standard Deviation 0.3
Ocufilcon B Then Ocufilcon D	Lens Fit - Decentration After Insertion	Vertical	-0.15 mm	Standard Deviation 0.48

Primary

Lens Fit - Decentration at One Week

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).

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Ocufilcon D Then Ocufilcon B	Lens Fit - Decentration at One Week	Horizontal	0.14 mm	Standard Deviation 0.36
Ocufilcon D Then Ocufilcon B	Lens Fit - Decentration at One Week	Vertical	-0.08 mm	Standard Deviation 0.39
Ocufilcon B Then Ocufilcon D	Lens Fit - Decentration at One Week	Horizontal	0.09 mm	Standard Deviation 0.37
Ocufilcon B Then Ocufilcon D	Lens Fit - Decentration at One Week	Vertical	-0.18 mm	Standard Deviation 0.51

Primary

Lens Fit - Post-Blink Lens Movement After Insertion

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).

Time frame: Baseline and 7 days from baseline visit

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

Arm	Measure	Value (MEAN)	Dispersion
Ocufilcon D Then Ocufilcon B	Lens Fit - Post-Blink Lens Movement After Insertion	0.29 mm	Standard Deviation 0.28
Ocufilcon B Then Ocufilcon D	Lens Fit - Post-Blink Lens Movement After Insertion	0.3 mm	Standard Deviation 0.32

Primary

Lens Fit - Post-Blink Lens Movement Prior to Removal

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).

Time frame: 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

Arm	Measure	Value (MEAN)	Dispersion
Ocufilcon D Then Ocufilcon B	Lens Fit - Post-Blink Lens Movement Prior to Removal	0.38 mm	Standard Deviation 0.32
Ocufilcon B Then Ocufilcon D	Lens Fit - Post-Blink Lens Movement Prior to Removal	0.48 mm	Standard Deviation 0.41

Primary

Lens Fit - Tightness After Insertion

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 ).

Time frame: Baseline and 7 days from baseline visit

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

Arm	Measure	Value (MEAN)	Dispersion
Ocufilcon D Then Ocufilcon B	Lens Fit - Tightness After Insertion	50.0 percentage of tightness	Standard Deviation 14.1
Ocufilcon B Then Ocufilcon D	Lens Fit - Tightness After Insertion	52.4 percentage of tightness	Standard Deviation 15.7

Primary

Lens Fit - Tightness at One Week

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 ).

Time frame: 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

Arm	Measure	Value (MEAN)	Dispersion
Ocufilcon D Then Ocufilcon B	Lens Fit - Tightness at One Week	42.4 percentage of tightness	Standard Deviation 12.9
Ocufilcon B Then Ocufilcon D	Lens Fit - Tightness at One Week	46 percentage of tightness	Standard Deviation 13.7

Secondary

Overall Lens Pair Preference

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.