CompletedNCT01873846Updated Jul 24, 2019Results posted

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

An interventional study of Silicone Hydrogel Contact Lens in Myopia, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Screening

Phase: Not applicable
Study type: Interventional
Enrollment: 400
Allocation: Not applicable
Ages: 18 Years to 35 Years
Sex: All

Study summary

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Conditions studied

Myopia

Browse trials for

Myopia 984

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 400 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

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

Inclusion criteria

Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye
Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
Subjects must habitually wear soft contact lens.
Subject must have no active ocular disease or allergic conjunctivitis.
Subject must not be using any topical ocular medications.
Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

Exclusion criteria

Exclusion Criteria:

Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Subjects with an active ocular disease or who are using any ocular medication.
Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
Subjects with any Grade 2 or greater finding during the slit lamp examination.
Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Subjects with any scar or neovascularization within the central 4 mm of the cornea.
Subjects who are aphakic.
Subjects who are amblyopic.
Subjects who have had any corneal surgery (eg, refractive surgery).
Subjects who are allergic to any component in the study care products.
Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 400 participants (actual)

Study arms

Experimental
Silicone Hydrogel Contact Lens
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Device: Silicone Hydrogel Contact Lens

Interventions

DeviceSilicone Hydrogel Contact Lens

What researchers measure

Primary outcomes

Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
Time frame: 7 days
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses
Time frame: 7 days
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses
Time frame: 7 days

Secondary outcomes

Lens Performance Assessment
High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
Time frame: 2 weeks
Any Graded Slit Lamp Finding > 2
Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.
Time frame: 2 weeks

Results

Posted Jul 24, 2019

Participant flow

Participant flow — Overall Study
Milestone	Silicone Hydrogel Contact Lens
Started	400
Eligble participants dispensed lenses	396
Completed	388
Not completed	12

Outcome measures

PrimaryPreference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?

Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses

Time frame:: 7 days
Reported as:: Count of participants · Participants

Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Participants	Silicone Hydrogel Contact Lens
Prefer study lenses	195
Prefer usual lenses	93
About the same as usual lens	92

PrimaryPreference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.

Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses

Time frame:: 7 days
Reported as:: Count of participants · Participants

Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Participants	Silicone Hydrogel Contact Lens
Prefer study lenses	199
Prefer usual lenses	80
About the same as usual lens	101

PrimaryPreference Question: These Contact Lenses Help Maintain Healthy, White Eyes.

Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses

Time frame:: 7 days
Reported as:: Count of participants · Participants

Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Participants	Silicone Hydrogel Contact Lens
Prefer study lenses	162
Prefer usual lenses	51
About the same as usual lens	167

SecondaryLens Performance Assessment

High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.

Time frame:: 2 weeks
Reported as:: Mean · Log of Minimum Angle of Resolution VA

Lens Performance Assessment
Log of Minimum Angle of Resolution VA	Silicone Hydrogel Contact Lens
Lens Performance Assessment	0.004 ± 0.067

SecondaryAny Graded Slit Lamp Finding > 2

Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.

Time frame:: 2 weeks
Reported as:: Count of units · Eyes

Any Graded Slit Lamp Finding > 2
Eyes	Silicone Hydrogel Contact Lens
Any Graded Slit Lamp Finding > 2	2

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Silicone Hydrogel Contact Lens	—	0/396 (0%)	0/396 (0%)

Baseline characteristics

Eligible participants dispensed lenses

Age, Continuous
Age, Continuous(years)	Silicone Hydrogel Contact Lens
Mean	26.8 ± 4.8

Sex: Female, Male
Sex: Female, Male(Participants)	Silicone Hydrogel Contact Lens
Female	278
Male	118

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Silicone Hydrogel Contact Lens
American Indian or Alaska Native	0
Asian	44
Native Hawaiian or Other Pacific Islander	2
Black or African American	14
White	327
More than one race	0
Unknown or Not Reported	9

Study locations

1 site

Bausch & Lomb Incorporated
Madison, New Jersey 07940, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01873846
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Jun 10, 2013
Start date: Apr 2013
Primary completion: May 2013
Completion: Jul 2013
Results posted: Jul 24, 2019
Last update: Jul 24, 2019

Study contacts

Johnson Varughese

study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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