Trial Outcomes & Findings for Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses (NCT NCT02248766)

Last Updated: 2020-08-03

Results Overview

Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Baseline, 1 week, 2 week, 4 week

Results posted on

2020-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Enfilcon A / Somofilcon A All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enfilcon A / Somofilcon A n=30 Participants All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens
Age, Continuous	23.4 years STANDARD_DEVIATION 2.7 • n=99 Participants
Sex: Female, Male Female	19 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Region of Enrollment Spain	30 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 week, 4 week

Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.

Outcome measures

Outcome measures
Measure	Enfilcon A n=30 Participants All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens	Somofilcon A at 1 Week n=30 Participants All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	Somofilcon A at 2 Week n=30 Participants All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	Somofilcon A at 4 Week n=30 Participants All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
Visual Acuity - Enfilcon A and Somofilcon A Oculus Dexter (OD)	-0.013 logMar Standard Deviation 0.03	-0.013 logMar Standard Deviation 0.03	-0.010 logMar Standard Deviation 0.03	-0.023 logMar Standard Deviation 0.03
Visual Acuity - Enfilcon A and Somofilcon A Oculus Sinister (OS)	-0.010 logMar Standard Deviation 0.03	-0.010 logMar Standard Deviation 0.03	-0.017 logMar Standard Deviation 0.03	-0.017 logMar Standard Deviation 0.03
Visual Acuity - Enfilcon A and Somofilcon A Binocular	-0.033 logMar Standard Deviation 0.05	-0.033 logMar Standard Deviation 0.05	-0.040 logMar Standard Deviation 0.05	-0.040 logMar Standard Deviation 0.05

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 week, 4 week

Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)

Outcome measures

Outcome measures
Measure	Enfilcon A n=30 Participants All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens	Somofilcon A at 1 Week n=30 Participants All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	Somofilcon A at 2 Week n=30 Participants All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	Somofilcon A at 4 Week n=30 Participants All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
Subjective Assessments- Enfilcon A and Somofilcon A Comfort prior to removal	8.13 units on a scale Standard Deviation 0.94	7.83 units on a scale Standard Deviation 0.80	7.20 units on a scale Standard Deviation 0.71	6.70 units on a scale Standard Deviation 0.99
Subjective Assessments- Enfilcon A and Somofilcon A Overall dryness	8.03 units on a scale Standard Deviation 0.67	7.77 units on a scale Standard Deviation 0.73	7.13 units on a scale Standard Deviation 0.86	6.70 units on a scale Standard Deviation 1.23
Subjective Assessments- Enfilcon A and Somofilcon A Handling	9.23 units on a scale Standard Deviation 0.63	9.20 units on a scale Standard Deviation 0.55	9.17 units on a scale Standard Deviation 0.46	9.00 units on a scale Standard Deviation 0.53
Subjective Assessments- Enfilcon A and Somofilcon A Overall lens fit	7.93 units on a scale Standard Deviation 0.69	7.90 units on a scale Standard Deviation 0.78	7.77 units on a scale Standard Deviation 0.76	8.13 units on a scale Standard Deviation 0.70
Subjective Assessments- Enfilcon A and Somofilcon A Overall vision satisfaction	8.30 units on a scale Standard Deviation 0.79	8.10 units on a scale Standard Deviation 0.69	7.60 units on a scale Standard Deviation 0.67	7.77 units on a scale Standard Deviation 0.62
Subjective Assessments- Enfilcon A and Somofilcon A Comfort on insertion	8.53 units on a scale Standard Deviation 1.00	8.43 units on a scale Standard Deviation 0.62	8.07 units on a scale Standard Deviation 0.64	7.50 units on a scale Standard Deviation 0.86
Subjective Assessments- Enfilcon A and Somofilcon A Comfort overall	8.10 units on a scale Standard Deviation 0.92	7.63 units on a scale Standard Deviation 0.77	7.10 units on a scale Standard Deviation 0.76	6.20 units on a scale Standard Deviation 1.10
Subjective Assessments- Enfilcon A and Somofilcon A Dryness during the day	8.47 units on a scale Standard Deviation 0.73	8.27 units on a scale Standard Deviation 0.64	7.63 units on a scale Standard Deviation 0.88	7.43 units on a scale Standard Deviation 1.13
Subjective Assessments- Enfilcon A and Somofilcon A Dryness prior to removal	8.23 units on a scale Standard Deviation 0.73	8.00 units on a scale Standard Deviation 0.79	7.33 units on a scale Standard Deviation 0.80	7.03 units on a scale Standard Deviation 0.96

Adverse Events

Enfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Somofilcon 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

Robert Montes-Mico, O.D., PhD

Optometry Research Group (GIO) University of Valencia

Phone: 34-9635-44764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. 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.
Publication restrictions are in place

Restriction type: OTHER