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Trial Outcomes & Findings for Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses (NCT NCT05725317)

NCT ID: NCT05725317

Last Updated: 2024-08-06

Results Overview

VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

Day 4

Results posted on

2024-08-06

Participant Flow

Participants were recruited from 7 investigative sites located in the United States.

Of the 114 enrolled, 1 participant was exited from the study prior to randomization as a screen failure. This reporting group includes all randomized participants (113).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure
LID220365 (OD) / LID006961 (OS)
LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
LID006961 (OD) / LID220365 (OS)
LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
Overall Study
STARTED
56 112
57 114
Overall Study
COMPLETED
56 112
57 114
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
LID220365 (OD) / LID006961 (OS)
n=56 Participants
LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
LID006961 (OD) / LID220365 (OS)
n=57 Participants
LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
Total
n=113 Participants
Total of all reporting groups
Age, Continuous
33.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
33.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
33.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male
Female
38 Participants
n=5 Participants
38 Participants
n=7 Participants
76 Participants
n=5 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
19 Participants
n=7 Participants
37 Participants
n=5 Participants
Race/Ethnicity, Customized
White
47 Participants
n=5 Participants
46 Participants
n=7 Participants
93 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Multi-racial
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
5 Participants
n=5 Participants
9 Participants
n=7 Participants
14 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
51 Participants
n=5 Participants
48 Participants
n=7 Participants
99 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 4

Population: Full Analysis Set

VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Outcome measures

Outcome measures
Measure
LID220365
n=113 eyes
LID220365 contact lens worn in the right eye (OD) or left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
LID006961
n=113 eyes
LID006961 contact lens worn in the right eye (OD) or left eye (OS), as randomized, for four days. A fresh pair of lenses was worn each day.
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
-0.13 logMAR
Standard Error 0.006
-0.13 logMAR
Standard Error 0.006

Adverse Events

Pretreatment

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

LID220365 Ocular

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

LID006961 Ocular

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

Overall Non-Ocular

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, Vision Care

Alcon Research, LLC

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