NCT03319212 is a NA clinical trial of senofilcon A contact lenses in Ametropia, sponsored by Johnson & Johnson Vision Care, Inc..

Who is sponsoring NCT03319212?

NCT03319212 is sponsored by Johnson & Johnson Vision Care, Inc..

What drugs are being tested in NCT03319212?

Interventions in NCT03319212: senofilcon A contact lenses.

Is NCT03319212 still recruiting?

NCT03319212 is currently completed. Last updated 15 October 2019.

Are results published for NCT03319212?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-15 · How we verify

NCT03319212

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Characterization of Symptomatic Populations

Completed NA Results posted Last updated 15 October 2019

What this trial tests

NA trial testing senofilcon A contact lenses in Ametropia in 105 participants. Completed in 15 August 2018.

Timeline

29 September 2017

Primary endpoint
15 August 2018

15 August 2018

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	29 September 2017
Primary completion	15 August 2018
Estimated completion	15 August 2018
Sites	2 locations across Canada, United States

Drugs / interventions tested

senofilcon A contact lenses

Conditions studied

Ametropia — all drugs for Ametropia →

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Ametropia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Meibomian Gland Imaging Primary · 4-Week Follow-up

Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.

Degree 0

Group	Value	95% CI
Asymptomatic	10
Symptomatic	4

Degree 1

Group	Value	95% CI
Asymptomatic	23
Symptomatic	66

Degree 2

Group	Value	95% CI
Asymptomatic	18
Symptomatic	16

Degree 3

Group	Value	95% CI
Asymptomatic	1
Symptomatic	8

Meibomian Gland Expressibility Primary · 4-Week Follow-up

Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian

Central Lower Lid

Group	Value	95% CI
Asymptomatic	9.04	± 5.068
Symptomatic	8.07	± 5.055

Temporal Lower Lid

Group	Value	95% CI
Asymptomatic	8.71	± 4.795
Symptomatic	7.94	± 4.803

Nasal Lower Lid

Group	Value	95% CI
Asymptomatic	7.94	± 4.976
Symptomatic	6.54	± 4.571

Total Score

Group	Value	95% CI
Asymptomatic	25.69	± 13.964
Symptomatic	22.55	± 12.649

Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings Primary · 4-Week Follow-up

Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal: * Irregularity: Notching of Margin * Vascularity of Lid Margin: Telangiectasia * Meibomian Gland Pouting, Plugging, or Capping * Lid/Lash Margin Debris Findings. The number of positive findings (yes) was reported for each group.

Irregularity: Notching of Margin

Group	Value	95% CI
Asymptomatic	1
Symptomatic	5

Vascularity of Lid Margin: Telangiectasia

Group	Value	95% CI
Asymptomatic	12
Symptomatic	21

Meibomian Gland Pouting, Plugging, or Capping

Group	Value	95% CI
Asymptomatic	12
Symptomatic	33

Lid/Lash Margin Debris Findings

Group	Value	95% CI
Asymptomatic	0
Symptomatic	10

Lid Wiper Epitheliopathy Primary · 4-Week Follow-up

Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades

Group	Value	95% CI
Asymptomatic	0.50	± 0.718
Symptomatic	0.28	± 0.489

Conjunctival Folds Primary · 4-Week Follow-up

Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm).

Temporal- Grade 0

Group	Value	95% CI
Asymptomatic	27
Symptomatic	45

Temporal- Grade 1

Group	Value	95% CI
Asymptomatic	22
Symptomatic	41

Temporal- Grade 2

Group	Value	95% CI
Asymptomatic	3
Symptomatic	8

Temporal- Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Nasal- Grade 0

Group	Value	95% CI
Asymptomatic	43
Symptomatic	55

Nasal- Grade 1

Group	Value	95% CI
Asymptomatic	9
Symptomatic	30

Nasal- Grade 2

Group	Value	95% CI
Asymptomatic	0
Symptomatic	9

Nasal- Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Conjunctival Redness Secondary · 4-Week Follow-up

Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe.

Bulbar-Nasal- Grade 0

Group	Value	95% CI
Asymptomatic	12
Symptomatic	11

Bulbar-Nasal- Grade 1

Group	Value	95% CI
Asymptomatic	36
Symptomatic	72

Bulbar-Nasal- Grade 2

Group	Value	95% CI
Asymptomatic	6
Symptomatic	13

Bulbar-Nasal- Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Bulbar-Nasal- Grade 4

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Bulbar-Temporal- Grade 0

Group	Value	95% CI
Asymptomatic	13
Symptomatic	12

Bulbar-Temporal- Grade 1

Group	Value	95% CI
Asymptomatic	37
Symptomatic	73

Bulbar-Temporal- Grade 2

Group	Value	95% CI
Asymptomatic	4
Symptomatic	11

Conjunctival Staining Secondary · 4-Week Follow-up

Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining).

Nasal- Grade 0

Group	Value	95% CI
Asymptomatic	17
Symptomatic	17

Nasal- Grade 1

Group	Value	95% CI
Asymptomatic	18
Symptomatic	51

Nasal- Grade 2

Group	Value	95% CI
Asymptomatic	19
Symptomatic	28

Nasal- Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Temporal- Grade 0

Group	Value	95% CI
Asymptomatic	20
Symptomatic	29

Temporal- Grade 1

Group	Value	95% CI
Asymptomatic	19
Symptomatic	51

Temporal- Grade 2

Group	Value	95% CI
Asymptomatic	15
Symptomatic	16

Temporal- Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Corneal Staining Secondary · 4-Week Follow-up

Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (\>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade

Staining Type- Central- Grade 0

Group	Value	95% CI
Asymptomatic	51
Symptomatic	88

Staining Type- Central- Grade 1

Group	Value	95% CI
Asymptomatic	1
Symptomatic	5

Staining Type- Central- Grade 2

Group	Value	95% CI
Asymptomatic	2
Symptomatic	3

Staining Type- Central- Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Staining Type-Inferior - Grade 0

Group	Value	95% CI
Asymptomatic	48
Symptomatic	75

Staining Type-Inferior - Grade 1

Group	Value	95% CI
Asymptomatic	5
Symptomatic	17

Staining Type-Inferior - Grade 2

Group	Value	95% CI
Asymptomatic	1
Symptomatic	4

Staining Type-Inferior - Grade 3

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Tear Film Lipid Layer Thickness Secondary · 4-Week Follow-up

Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm.

Group	Value	95% CI
Asymptomatic	66.81	± 19.336
Symptomatic	63.00	± 16.208

Tear Film Stability Secondary · 4-Week Follow-up

Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group.

Group	Value	95% CI
Asymptomatic	8.03	± 3.846
Symptomatic	6.78	± 4.327

Tear Film Lipid Pattern Secondary · 4-Week Follow-up

Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other.

None

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Open Meshwork

Group	Value	95% CI
Asymptomatic	6
Symptomatic	24

Closed (Tight)

Group	Value	95% CI
Asymptomatic	18
Symptomatic	22

Flow (Wave)

Group	Value	95% CI
Asymptomatic	14
Symptomatic	28

Amorphous

Group	Value	95% CI
Asymptomatic	11
Symptomatic	15

Colors

Group	Value	95% CI
Asymptomatic	3
Symptomatic	5

Others

Group	Value	95% CI
Asymptomatic	0
Symptomatic	0

Sponsor's own description

This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of senofilcon A contact lenses

Trials testing the same drug.

NCT03349632 — Clinical Comparison of 4 Daily Disposable Soft Contact Lenses · NA · completed

Other recruiting trials for Ametropia

Currently open trials in the same condition.

NCT06668246 — Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS) · active not recruiting
NCT04632784 — Clinical Trial With Artiflex Presbyopic (Artiplus) · NA · active not recruiting

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

NCT07443215 — Evaluation of Effect of Scatter on Visual Performance · NA · recruiting
NCT07174596 — Evaluation of Approved Contact Lenses · NA · completed
NCT07076160 — Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses · NA · completed
NCT06967129 — Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process · NA · completed
NCT06864858 — Clinical Evaluation of Two Cosmetic Contact Lenses · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03319212 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 15 October 2019

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/NCT03319212.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing