Trial Outcomes & Findings for Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens (NCT NCT01354223)

NCT ID: NCT01354223

Last Updated: 2020-07-29

Results Overview

The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: Change from baseline visit and all follow-ups visits
• Results posted on: 2020-07-29

Participant Flow

Ninety-three subjects evaluated, 3 subjects found to be ineligible and not randomized or dispensed. 90 adapted single-vision contact lens wearers with myopia were randomized and dispensed on a 2 to 1 ratio within each site and across entire study. Subjects used that same assigned product throughout study duration

Participant milestones

Measure	Stenfilcon A Contact Lens Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Study STARTED	60	30
Overall Study COMPLETED	57	29
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Stenfilcon A Contact Lens Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

Baseline characteristics by cohort

Measure	Stenfilcon A Contact Lens n=60 Participants Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=30 Participants Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode	Total n=90 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	60 Participants n=5 Participants	30 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.6 years STANDARD_DEVIATION 8.884 • n=5 Participants	29.8 years STANDARD_DEVIATION 8.550 • n=7 Participants	31.7 years STANDARD_DEVIATION 8.822 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	21 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	30 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline visit and all follow-ups visits

Population: Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings

The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.

The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.

Outcome measures

Measure	Stenfilcon A Contact Lens n=114 unique eyes Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=58 unique eyes Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Objective Assessment: Ocular Response - Biomicroscopy Neovascularization, Baseline	1.00 units on a scale Interval 1.0 to 1.0	1.00 units on a scale Interval 1.0 to 1.0
Objective Assessment: Ocular Response - Biomicroscopy Neovascularization, All Follow-up	1.00 units on a scale Interval 1.0 to 1.0	1.10 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Corneal Staining, Baseline	1.00 units on a scale Interval 1.0 to 1.0	1.00 units on a scale Interval 1.0 to 1.0
Objective Assessment: Ocular Response - Biomicroscopy Corneal Staining, All Follow-up	1.09 units on a scale Interval 1.0 to 2.0	1.18 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Limbal Hyperemia, Baseline	1.00 units on a scale Interval 1.0 to 1.0	1.00 units on a scale Interval 1.0 to 1.0
Objective Assessment: Ocular Response - Biomicroscopy Limbal Hyperemia, All Follow-up	1.03 units on a scale Interval 1.0 to 2.0	1.05 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Bulbar Hyperemia, Baseline	1.00 units on a scale Interval 1.0 to 1.0	1.00 units on a scale Interval 1.0 to 1.0
Objective Assessment: Ocular Response - Biomicroscopy Bulbar Hyperemia, All Follow-up	1.05 units on a scale Interval 1.0 to 2.0	1.02 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Palperbral Conjunctiva, Baseline	1.10 units on a scale Interval 1.0 to 2.0	1.00 units on a scale Interval 1.0 to 1.0
Objective Assessment: Ocular Response - Biomicroscopy Palpebral Conjunctiva, All Follow-up	1.38 units on a scale Interval 1.0 to 2.0	1.00 units on a scale Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: Any occurrence from dispensing to month 3 visit

Population: Unique eyes are defined as each individual eye in the study.

The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.

The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).

Outcome measures

Measure	Stenfilcon A Contact Lens n=114 unique eyes Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=58 unique eyes Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes	7 number of adverse events	1 number of adverse events

PRIMARY outcome

Timeframe: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined

Population: For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.

The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.

Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.

Outcome measures

Measure	Stenfilcon A Contact Lens n=562 possible examinations Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=288 possible examinations Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better	99.3 percentage of possible examinations	100 percentage of possible examinations

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Population: Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.

The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.

Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).

Outcome measures

Measure	Stenfilcon A Contact Lens n=114 unique eyes Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=58 unique eyes Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort Baseline	73.6 percentage of eyes	70.4 percentage of eyes
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort Week 1	43.9 percentage of eyes	50.0 percentage of eyes
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort Week 2	60.9 percentage of eyes	55.2 percentage of eyes
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort Month 1	55.4 percentage of eyes	60.3 percentage of eyes
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort Month 2	59.6 percentage of eyes	55.2 percentage of eyes
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort Month 3	55.3 percentage of eyes	58.6 percentage of eyes

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.

Outcome measures

Measure	Stenfilcon A Contact Lens n=57 Participants Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=29 Participants Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn Month 2	13.81 hours Standard Deviation 2.774	13.41 hours Standard Deviation 2.693
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn Baseline	15.04 hours Standard Deviation 3.846	13.74 hours Standard Deviation 4.182
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn Week 1	13.71 hours Standard Deviation 2.281	13.18 hours Standard Deviation 2.539
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn Week 2	13.69 hours Standard Deviation 2.235	13.31 hours Standard Deviation 2.523
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn Month 1	13.67 hours Standard Deviation 2.520	12.81 hours Standard Deviation 2.640
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn Month 3	14.00 hours Standard Deviation 2.440	13.28 hours Standard Deviation 2.576

Adverse Events

Stenfilcon A Contact Lens

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ocufilcon B Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Stenfilcon A Contact Lens n=60 participants at risk Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Ocufilcon B Contact Lens n=30 participants at risk Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Eye disorders Papillary Conjunctivitis	5.0% 3/60 • Number of events 6	0.00% 0/30

Additional Information

William J. Gleason, O.D.

Foresight Regulatory Strategies, Inc.

Phone: 978-658-6888

Results disclosure agreements

• Principal investigator is a sponsor employee Release of this data (through presentation, publication or other written or oral communication) to other than listed personnel (listed in protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnel are prohibited from acknowledging participation in the study to individuals and organizations except those listed.
• Publication restrictions are in place

Restriction type: OTHER