NCT02543528 is a NA clinical trial of Investigational Lens 1 in Visual Disorder, sponsored by Johnson & Johnson Vision Care, Inc..

Who is sponsoring NCT02543528?

NCT02543528 is sponsored by Johnson & Johnson Vision Care, Inc..

What drugs are being tested in NCT02543528?

Interventions in NCT02543528: Investigational Lens 1, Investigational Lens 2, Investigational Lens 3, etafilcon A (Reusable), etafilcon A (1-Day).

What condition does NCT02543528 study?

NCT02543528 studies Visual Disorder.

Is NCT02543528 still recruiting?

NCT02543528 is currently completed. Last updated 1 October 2019.

Are results published for NCT02543528?

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

Last reviewed 2019-10-01 · How we verify

NCT02543528

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

A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week

Completed NA Results posted Last updated 1 October 2019

What this trial tests

NA trial testing Investigational Lens 1 in Visual Disorder in 171 participants. Completed in 8 November 2016.

Timeline

1 June 2015

Primary endpoint
8 November 2016

8 November 2016

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	171
Start date	1 June 2015
Primary completion	8 November 2016
Estimated completion	8 November 2016
Sites	1 location across India

Drugs / interventions tested

Investigational Lens 1
Investigational Lens 2
Investigational Lens 3
etafilcon A (Reusable)
etafilcon A (1-Day)

Conditions studied

Visual Disorder — all drugs for Visual Disorder →

Sponsor

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

Who can join

Adults 18 to 39, any sex, with Visual Disorder. 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.

Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE) Primary · Up to 6 months

The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.

Group	Value	95% CI
Investigational Lens 1	14
Investigational Lens 3	13
Investigational Lens 2	12
Etafilcon A (Resuable)	1

Overall Comfort Score Secondary · Time Frame Up to 6 months

Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and

1-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	59.39	± 14.263
Investigational Lens 1	60.22	± 9.005
Investigational Lens 2	58.85	± 13.102
Etafilcon A (Resuable)	62.51	± 13.431

5-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	58.38	± 9.293
Investigational Lens 1	60.12	± 8.447
Investigational Lens 2	58.29	± 9.735
Etafilcon A (Resuable)	64.59	± 13.301

12-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	60.94	± 9.620
Investigational Lens 1	65.74	± 12.091
Investigational Lens 2	58.95	± 13.457
Etafilcon A (Resuable)	64.87	± 13.831

26-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	60.20	± 12.851
Investigational Lens 1	65.41	± 16.467
Investigational Lens 2	57.35	± 15.280
Etafilcon A (Resuable)	65.57	± 14.513

88-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	59.54	± 7.474
Investigational Lens 1	55.59	± 15.247
Investigational Lens 2	57.71	± 12.150
Etafilcon A (Resuable)	65.00	± 15.657

180-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	57.81	± 9.133
Investigational Lens 1	62.69	± 14.600
Investigational Lens 2	54.91	± 7.578
Etafilcon A (Resuable)	64.49	± 16.120

Overall Vision Score Secondary · Time Frame Up to 6 months

Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26

1-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	55.27	± 15.819
Investigational Lens 1	56.78	± 14.299
Investigational Lens 2	52.87	± 12.857
Etafilcon A (Resuable)	60.28	± 14.723

5-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	53.02	± 9.117
Investigational Lens 1	54.66	± 14.398
Investigational Lens 2	52.11	± 13.284
Etafilcon A (Resuable)	59.55	± 15.169

12-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	52.17	± 13.614
Investigational Lens 1	59.63	± 17.147
Investigational Lens 2	50.73	± 11.715
Etafilcon A (Resuable)	59.59	± 14.892

26-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	52.85	± 5.218
Investigational Lens 1	57.84	± 13.257
Investigational Lens 2	50.38	± 17.434
Etafilcon A (Resuable)	59.76	± 14.244

88-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	50.23	± 17.080
Investigational Lens 1	54.22	± 14.718
Investigational Lens 2	50.67	± 10.777
Etafilcon A (Resuable)	63.83	± 17.096

180-Day Follow-up

Group	Value	95% CI
Investigational Lens 3	53.49	± 9.883
Investigational Lens 1	54.07	± 10.654
Investigational Lens 2	50.92	± 9.699
Etafilcon A (Resuable)	61.68	± 16.426

Adverse events — posted to ClinicalTrials.gov

Time frame: Throughout the entire duration of the study. Approximately 6 months per subject.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Etafilcon A (1-Day)

Serious: 0/168 (0%)

Deaths: 0/168

Investigational Lens 1

Serious: 0/36 (0%)

Deaths: 0/36

Investigational Lens 2

Serious: 0/35 (0%)

Deaths: 0/35

Investigational Lens 3

Serious: 3/36 (8%)

Deaths: 0/36

Etafilcon A (Resuable)

Serious: 1/35 (3%)

Deaths: 0/35

Serious adverse events (1 terms)

Reaction	System	Etafilcon A (1-Day)	Investigational Lens 1	Investigational Lens 2	Investigational Lens 3	Etafilcon A (Resuable)
Iritis	Eye disorders	—	—	—	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Etafilcon A (1-Day)	Investigational Lens 1	Investigational Lens 2	Investigational Lens 3	Etafilcon A (Resuable)
CLPU (Contact Lens induced Peripheral Ulcer)	Eye disorders	—	—	—	—	—
Asymptomatic Corneal Scar	Eye disorders	—	—	—	—	—
Fever	Immune system disorders	—	—	—	—	—
Symptoms Problems or Complaints Requiring Treatment	Eye disorders	—	—	—	—	—
NSIE (Non-significant Infiltrative Event)	Eye disorders	—	—	—	—	—
Corneal Foreign Body	Eye disorders	—	—	—	—	—
SPK (Superficial Punctate Keratitis)	Eye disorders	—	—	—	—	—
SIE (Significant Infiltrative Event)	Eye disorders	—	—	—	—	—
CLPC (Contact Lens Papillary Conjunctivitis)	Eye disorders	—	—	—	—	—
Meibomianitis	Eye disorders	—	—	—	—	—
Slit Lamp Findings Grade 2 or less requiring treatment	Eye disorders	—	—	—	—	—

Most-reported serious reactions: Iritis.

Data from ClinicalTrials.gov NCT02543528 adverse events section.

Sponsor's own description

This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of \~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.

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 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 NCT02543528 (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: 1 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/NCT02543528.

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