Trial Outcomes & Findings for Performance of Two Toric Silicone Hydrogel Contact Lenses (NCT NCT03578926)

NCT ID: NCT03578926

Last Updated: 2019-12-10

Results Overview

Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-12-10

Participant Flow

45 habitual lens wearers were enrolled. 1 participant was ineligible for the study due to an unacceptable lens fit. 44 participants were dispensed and completed all study visits.

Participant milestones

Measure	Fanfilcon A Toric Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. Contact Lens: fanfilcon A toric	Senofilcon A Toric Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. Contact Lens: senofilcon A toric
First Intervention STARTED	21	23
First Intervention COMPLETED	21	23
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	23	21
Second Intervention COMPLETED	23	21
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=44 Participants All subjects are randomized to 2-week cross-over study to compare fanfilcon A and senofilcon A.
Age, Categorical <=18 years	0 Participants n=44 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=44 Participants
Age, Categorical >=65 years	0 Participants n=44 Participants
Age, Continuous	25 years STANDARD_DEVIATION 7.2 • n=44 Participants
Sex: Female, Male Female	30 Participants n=44 Participants
Sex: Female, Male Male	14 Participants n=44 Participants
Region of Enrollment Mexico	44 participants n=44 Participants

PRIMARY outcome

Timeframe: Baseline

Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Lens Centration	44 Participants	44 Participants

PRIMARY outcome

Timeframe: 2 weeks

Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Lens Centration Optimal Centration	44 Participants	44 Participants
Lens Centration Decentration Acceptable	0 Participants	0 Participants
Lens Centration Decentration unacceptable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline

Lens covering the cornea (Yes, No)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Corneal Coverage Yes	44 Participants	44 Participants
Corneal Coverage No	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

Lens covering the cornea (Yes, No)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Corneal Coverage Yes	44 Participants	44 Participants
Corneal Coverage No	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline

Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Post Blink Movement	1.91 units on a scale Standard Deviation 0.3	1.98 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: 2 weeks

Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Post Blink Movement	2.00 units on a scale Standard Deviation 0.0	2.02 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 2 weeks

Average daily wearing time (hours/day)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Wearing Time	12.2 hours/day Standard Deviation 2.9	11.6 hours/day Standard Deviation 3.1

SECONDARY outcome

Timeframe: 2 weeks

Comfortable daily wearing time (hours/day)

Outcome measures

Measure	Fanfilcon A n=44 Participants Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Senofilcon A n=44 Participants Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Comfortable Wearing Time	10.0 hours/day Standard Deviation 3.2	9.0 hours/day Standard Deviation 3.0

Adverse Events

Fanfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A

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

Jose A. Vega, O.D., MSc., FAAO

CooperVision Inc.

Phone: 9256213761

Email: javega@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place