Trial Outcomes & Findings for Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens (NCT NCT04085328)

Last Updated: 2023-06-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

675 participants

Primary outcome timeframe

Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up

Results posted on

2023-06-13

Participant Flow

The study population consisted of a Primary cohort, including subjects of any race/ethnic background at 35 Primary cohort sites, and a Supplemental cohort, including subjects of Chinese race only at 7 Supplemental cohort sites.

Of the 675 enrolled, 30 participants were exited from the study as screen failures prior to randomization. This reporting group includes all enrolled and dispensed participants (645).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Biofinity Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	LID015385 LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.
Overall Study STARTED	323 646	322 644
Overall Study Primary Cohort Started	291 582	290 580
Overall Study Primary Cohort Completed	256 512	257 514
Overall Study Primary Cohort Discontinued	35 70	33 66
Overall Study COMPLETED	285 570	286 572
Overall Study NOT COMPLETED	38 76	36 72

Reasons for withdrawal

Reasons for withdrawal
Measure	Biofinity Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	LID015385 LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.
Overall Study Witihdrew Consent	16	16
Overall Study Adverse Event	8	7
Overall Study Lost to Follow-up	7	2
Overall Study Physician Decision	0	1
Overall Study Pregnancy	0	1
Overall Study Reasons Related to COVID-19	5	8
Overall Study Did not meet inclusion criteria	1	1
Overall Study Early termination	1	0

Baseline Characteristics

Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofinity n=323 Participants Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	LID015385 n=322 Participants LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	Total n=645 Participants Total of all reporting groups
Age, Continuous	33.3 years STANDARD_DEVIATION 8.3 • n=5 Participants	34.2 years STANDARD_DEVIATION 9.5 • n=7 Participants	33.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	202 Participants n=5 Participants	197 Participants n=7 Participants	399 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	125 Participants n=7 Participants	246 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	295 Participants n=5 Participants	289 Participants n=7 Participants	584 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	254 Participants n=5 Participants	262 Participants n=7 Participants	516 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	323 participants n=5 Participants	322 participants n=7 Participants	645 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up

Population: This analysis population includes all enrolled dispensed subjects/eyes completing the study, with data at scheduled study visit. This outcome measure was pre-specified for the Primary Cohort.

Outcome measures

Outcome measures
Measure	Biofinity n=512 eyes Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	LID015385 n=514 eyes LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Day 1 Dispense	-0.05 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Hour 24 Follow-up	-0.05 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.07
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Week 1 Follow-up	-0.05 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.07
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Month 1 Follow-up	-0.05 logMAR Standard Deviation 0.07	-0.05 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Month 2 Follow-up	-0.06 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Month 3 Follow-up	-0.06 logMAR Standard Deviation 0.07	-0.05 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Month 6 Follow-up	-0.06 logMAR Standard Deviation 0.06	-0.06 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Month 9 Follow-up	-0.06 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes Month 12 Follow-up/Exit	-0.06 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up

Population: This analysis population includes all enrolled and dispensed subjects/eyes not completing the study, with data at scheduled study visit. This outcome measure was pre-specified for the Primary Cohort.

Outcome measures

Outcome measures
Measure	Biofinity n=70 eyes Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	LID015385 n=66 eyes LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Day 1 Dispense	-0.04 logMAR Standard Deviation 0.06	-0.06 logMAR Standard Deviation 0.07
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Hour 24 Follow-up	-0.03 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.07
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Week 1 Follow-up	-0.05 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.08
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Month 1 Follow-up	-0.04 logMAR Standard Deviation 0.06	-0.05 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Month 2 Follow-up	-0.06 logMAR Standard Deviation 0.06	-0.04 logMAR Standard Deviation 0.11
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Month 3 Follow-up	-0.05 logMAR Standard Deviation 0.06	-0.02 logMAR Standard Deviation 0.07
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Month 6 Follow-up	-0.07 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.06
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes Month 9 Follow-up	-0.08 logMAR Standard Deviation 0.06	-0.12 logMAR Standard Deviation 0.00

PRIMARY outcome

Timeframe: Up to Month 12

Population: This analysis population includes all enrolled subjects who were also dispensed. This outcome measure was pre-specified for the Primary Cohort.

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).

Outcome measures

Outcome measures
Measure	Biofinity n=582 eyes Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.	LID015385 n=580 eyes LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must have slept 1 night per week without lenses. Lenses were replaced as specified in the study protocol.
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)	0.0258 proportion of eyes	0.0103 proportion of eyes

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Ocular

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Nonocular

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Nonocular

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=645 participants at risk Events reported in this group occurred prior to dispense of the study contact lenses	Control Ocular n=646 participants at risk Events reported in this group occurred following dispense of the comfilcon A contact lenses	Control Nonocular n=323 participants at risk Events reported in this group occurred following dispense of the comfilcon A contact lenses	Test Ocular n=644 participants at risk Events reported in this group occurred following dispense of the LID015385 contact lenses	Test Nonocular n=322 participants at risk Events reported in this group occurred following dispense of the LID015385 contact lenses
Eye disorders Ulcerative keratitis	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.62% 4/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.
Infections and infestations Hypopyon	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.15% 1/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.31% 1/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.31% 1/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.31% 1/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.31% 1/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.
Surgical and medical procedures Intervertebral disc operation	0.00% 0/645 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/646 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/323 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.00% 0/644 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.	0.31% 1/322 • Adverse events (AE's) were collected from time of consent to study exit, approximately 12 months. AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all enrolled and dispensed subjects.

Other adverse events

Adverse event data not reported

Additional Information

Expert CDMA Project Lead, Vision Care

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

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