Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Day 1 Dispense
Group
Value
95% CI
Biofinity
-0.04
± 0.06
LID015385
-0.06
± 0.07
Hour 24 Follow-up
Group
Value
95% CI
Biofinity
-0.03
± 0.06
LID015385
-0.05
± 0.07
Week 1 Follow-up
Group
Value
95% CI
Biofinity
-0.05
± 0.06
LID015385
-0.05
± 0.08
Month 1 Follow-up
Group
Value
95% CI
Biofinity
-0.04
± 0.06
LID015385
-0.05
± 0.06
Month 2 Follow-up
Group
Value
95% CI
Biofinity
-0.06
± 0.06
LID015385
-0.04
± 0.11
Month 3 Follow-up
Group
Value
95% CI
Biofinity
-0.05
± 0.06
LID015385
-0.02
± 0.07
Month 6 Follow-up
Group
Value
95% CI
Biofinity
-0.07
± 0.06
LID015385
-0.07
± 0.06
Month 9 Follow-up
Group
Value
95% CI
Biofinity
-0.08
± 0.06
LID015385
-0.12
± 0.00
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)Primary· Up to Month 12
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).
Group
Value
95% CI
Biofinity
0.0258
LID015385
0.0103
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Alcon Research
Last refreshed: 13 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04085328.