CompletedNCT03459131Updated Mar 5, 2019Results posted

Clinical Evaluation of Two Monthly Contact Lenses

An interventional study of Comfilcon A with Digital Zone Optics™ contact lenses and Comfilcon A contact lenses in Refractive Errors, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Alcon Research · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: All

Study summary

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

Conditions studied

Refractive Errors

Browse trials for

Refractive Errors 412

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Able to understand and sign an approved informed consent form (ICF);
Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
Refractive, ocular, or intraocular surgery, as specified in the protocol;
Current or history of eye injury or disorders, as specified in the protocol;
Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Use of topical ocular medications that would require instillation during contact lens wear;
Other protocol-specified exclusion criteria may apply.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 15 participants (actual)

Study arms

Other
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.
Device: Comfilcon A with Digital Zone Optics™ contact lenses · Device: Comfilcon A contact lenses
Other
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.
Device: Comfilcon A with Digital Zone Optics™ contact lenses · Device: Comfilcon A contact lenses

Interventions

DeviceComfilcon A with Digital Zone Optics™ contact lenses
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
Also known as: BIOFINITY® ENERGYS™
DeviceComfilcon A contact lenses
Silicone hydrogel spherical contact lenses
Also known as: BIOFINITY®

What researchers measure

Primary outcomes

Subjective Rating of Overall Vision
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.
Time frame: Day 7, each product

Secondary outcomes

Over-refraction
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.
Time frame: Day 1 (Dispense), each product

Results

Posted Mar 5, 2019

Participant flow

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

Period 1, First 7 Days of Wear

Participant flow — Period 1, First 7 Days of Wear
Milestone	BIOFINITY ENERGYS Then BIOFINITY	BIOFINITY Then BIOFINITY ENERGYS
Started	7	8
Completed	7	8
Not completed	0	0

Period 2, Second 7 Days of Wear

Participant flow — Period 2, Second 7 Days of Wear
Milestone	BIOFINITY ENERGYS Then BIOFINITY	BIOFINITY Then BIOFINITY ENERGYS
Started	7	8
Completed	7	8
Not completed	0	0

Outcome measures

PrimarySubjective Rating of Overall Vision

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.

Time frame:: Day 7, each product
Reported as:: Mean · units on a scale

Subjective Rating of Overall Vision
units on a scale	BIOFINITY ENERGYS	BIOFINITY
Subjective Rating of Overall Vision	8.6 ± 1.2	8.6 ± 1.1

SecondaryOver-refraction

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.

Time frame:: Day 1 (Dispense), each product
Reported as:: Count of units · Eyes

Over-refraction
Eyes	BIOFINITY ENERGYS	BIOFINITY
-0.25D	3	0
0.00D	26	24
+0.25D	1	6

Adverse events

Collected over Dispense through study completion, an average of 14 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BIOFINITY ENERGYS	0/15 (0%)	0/15 (0%)	0/15 (0%)
BIOFINITY	0/15 (0%)	0/15 (0%)	0/15 (0%)

Baseline characteristics

This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).

Age, Continuous
Age, Continuous(years)	Overall
Mean	28.3 ± 3.6

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	9
Male	6

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Overall
White	14
Black or African American	0
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Other	1
Multi-Racial	0

Study locations

1 site

Alcon Investigative Site
Maitland, Florida 32751, United States

References and documents

Study documents

Study protocol · Mar 1, 2018
Statistical analysis plan · Mar 1, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03459131
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Mar 8, 2018
Start date: Mar 7, 2018
Primary completion: Mar 26, 2018
Completion: Mar 26, 2018
Results posted: Mar 5, 2019
Last update: Mar 5, 2019

Study contacts

Alcon, A Novartis Division

study director · Alcon, A Novartis Division

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Refractive Errors→

Other studies from this sponsor

Alcon Research

Start the discussion