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Trial Outcomes & Findings for Clinical Evaluation of Two Monthly Contact Lenses (NCT NCT03459131)

NCT ID: NCT03459131

Last Updated: 2019-03-05

Results Overview

Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Day 7, each product

Results posted on

2019-03-05

Participant Flow

Subjects were recruited from one study site located in the US.

All 15 enrolled subjects were randomized and exposed to investigational product. This reporting group includes all randomized and treated subjects (15).

Participant milestones

Participant milestones
Measure
BIOFINITY ENERGYS Then BIOFINITY
Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
BIOFINITY Then BIOFINITY ENERGYS
Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Period 1, First 7 Days of Wear
STARTED
7
8
Period 1, First 7 Days of Wear
COMPLETED
7
8
Period 1, First 7 Days of Wear
NOT COMPLETED
0
0
Period 2, Second 7 Days of Wear
STARTED
7
8
Period 2, Second 7 Days of Wear
COMPLETED
7
8
Period 2, Second 7 Days of Wear
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Two Monthly Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=15 Participants
Comfilcon A with Digital Zone Optics™ contact lenses and comfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Age, Continuous
28.3 years
STANDARD_DEVIATION 3.6 • n=113 Participants
Sex: Female, Male
Female
9 Participants
n=113 Participants
Sex: Female, Male
Male
6 Participants
n=113 Participants
Race/Ethnicity, Customized
White
14 Participants
n=113 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=113 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=113 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=113 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=113 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=113 Participants
Race/Ethnicity, Customized
Multi-Racial
0 Participants
n=113 Participants

PRIMARY outcome

Timeframe: Day 7, each product

Population: Safety Analysis Set

Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.

Outcome measures

Outcome measures
Measure
BIOFINITY ENERGYS
n=15 Participants
Comfilcon A with Digital Zone Optics™ contact lenses worn during Period 1 or Period 2 for 7 days.
BIOFINITY
n=15 Participants
Comfilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
Subjective Rating of Overall Vision
8.6 units on a scale
Standard Deviation 1.2
8.6 units on a scale
Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 1 (Dispense), each product

Population: Safety Analysis Set

Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.

Outcome measures

Outcome measures
Measure
BIOFINITY ENERGYS
n=30 Eyes
Comfilcon A with Digital Zone Optics™ contact lenses worn during Period 1 or Period 2 for 7 days.
BIOFINITY
n=30 Eyes
Comfilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
Over-refraction
-0.25D
3 Eyes
0 Eyes
Over-refraction
0.00D
26 Eyes
24 Eyes
Over-refraction
+0.25D
1 Eyes
6 Eyes

Adverse Events

BIOFINITY ENERGYS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

BIOFINITY

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

Sr Clinical Project Lead, GCRA - Vision Care

Alcon, A Novartis Division

Phone: 1-888-451-3937

Results disclosure agreements

  • Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
  • Publication restrictions are in place

Restriction type: OTHER