Trial Outcomes & Findings for Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens (NCT NCT01706770)

Last Updated: 2020-10-05

Results Overview

The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A 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/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits

Results posted on

2020-10-05

Participant Flow

52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.

Participant milestones

Participant milestones
Measure	Enfilcon A The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Galyfilcon A The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Overall Study STARTED	33	17
Overall Study COMPLETED	31	17
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Enfilcon A The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Galyfilcon A The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enfilcon A n=33 Participants The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Galyfilcon A n=17 Participants The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Total n=50 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	33 Participants n=5 Participants	17 Participants n=7 Participants	50 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	34.8 years STANDARD_DEVIATION 11.11 • n=5 Participants	33.8 years STANDARD_DEVIATION 11.50 • n=7 Participants	34.4 years STANDARD_DEVIATION 11.13 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	12 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	17 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline/dispensing visits, post-dispensing 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.

Outcome measures

PRIMARY outcome

Timeframe: Any occurrence from baseline to 1 month visit

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

The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A 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 from Baseline through end of month 1 visit.

Outcome measures

Outcome measures
Measure	Enfilcon A n=62 eyes The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Galyfilcon A n=34 eyes The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes	0 number of adverse events	2 number of adverse events

Adverse Events

Enfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Galyfilcon A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Enfilcon A n=33 participants at risk The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Galyfilcon A n=17 participants at risk The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Eye disorders Temporary Discontinuation of Lens Wear	0.00% 0/33 • From dispense up to one month on both the study lenses, a total of two months.	5.9% 1/17 • Number of events 1 • From dispense up to one month on both the study lenses, a total of two months.

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 (see protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnelare prohibited from acknowledging participation in the study to individuals and organizations except those listed.
Publication restrictions are in place

Restriction type: OTHER

Measure	Enfilcon A n=62 unique eyes The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Galyfilcon A n=34 unique eyes The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Objective Assessment: Ocular Response - Biomicroscopy Epithelial Edema, Baseline/Dispensing	1.00 units on a scale Interval 1.0 to 1.0	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.
Objective Assessment: Ocular Response - Biomicroscopy Epithelial Edema, Post-Dispensing	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.
Objective Assessment: Ocular Response - Biomicroscopy Epithelial Edema, All Follow-up	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.
Objective Assessment: Ocular Response - Biomicroscopy Stromal Edema, Basline/Dispensing	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.
Objective Assessment: Ocular Response - Biomicroscopy Stromal Edema, Post-Dispensing	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.
Objective Assessment: Ocular Response - Biomicroscopy Stromal Edema, All Follow-up	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.
Objective Assessment: Ocular Response - Biomicroscopy Neovascularization, Baseline/Dispensing	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, Post-Dispensing	NA units on a scale Interval 0.0 to 0.0 No participants experienced greater than 0 at this time point.	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	1.00 units on a scale Interval 1.0 to 1.0
Objective Assessment: Ocular Response - Biomicroscopy Corneal Staining, Baseline/Dispensing	1.06 units on a scale Interval 1.0 to 2.0	1.08 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Corneal Staining, Post-Dispensing	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	1.02 units on a scale Interval 1.0 to 2.0	1.04 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Limbal Hyperemia, Baseline/Dispensing	1.07 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 Limbal Hyperemia, Post-Dispensing	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	1.00 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, Baseline/Dispensing	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, Post-Dispensing	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	1.00 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 Palpebral Conjunctiva, Baseline/Dispensing	1.11 units on a scale Interval 1.0 to 2.0	1.12 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Palpebral Conjunctiva, Post-Dispensing	1.00 units on a scale Interval 1.0 to 1.0	1.14 units on a scale Interval 1.0 to 2.0
Objective Assessment: Ocular Response - Biomicroscopy Palpebral Conjunctiva, All Follow-up	1.05 units on a scale Interval 1.0 to 2.0	1.16 units on a scale Interval 1.0 to 2.0