NCT01180777

Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Completed NA Results posted Last updated 19 June 2018

What this trial tests

NA trial testing etafilcon A (A) in Myopia in 95 participants. Completed in 1 August 2010.

Timeline

1 July 2010

Primary endpoint
1 August 2010

1 August 2010

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	1 July 2010
Primary completion	1 August 2010
Estimated completion	1 August 2010
Sites	6 locations across United States

Drugs / interventions tested

• etafilcon A (A)
• etafilcon A (B)
• etafilcon A (C)

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

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

Who can join

Adults 18 to 40, female only, with Myopia. 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.

Lens Fit Acceptance Primary · 10-15 minutes post lens fit

Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.

Acceptable

Group	Value	95% CI
Etafilcon A (A)	158
Etafilcon A (B)	158
Etafilcon A (C)	157

Unacceptable

Group	Value	95% CI
Etafilcon A (A)	0
Etafilcon A (B)	2
Etafilcon A (C)	0

Binocular Snellen Visual Acuity (VA) Secondary · 10-15 minutes post lens fit

Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.

20/15

Group	Value	95% CI
Etafilcon A (A)	42
Etafilcon A (B)	39
Etafilcon A (C)	45

20/20

Group	Value	95% CI
Etafilcon A (A)	36
Etafilcon A (B)	39
Etafilcon A (C)	33

Corneal Staining Secondary · After 6-9 days of lens wear

Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.

Central region grade > 0

Group	Value	95% CI
Etafilcon A (A)	4
Etafilcon A (B)	6
Etafilcon A (C)	3

Inferior region grade > 0

Group	Value	95% CI
Etafilcon A (A)	34
Etafilcon A (B)	25
Etafilcon A (C)	44

Nasal region grade > 0

Group	Value	95% CI
Etafilcon A (A)	2
Etafilcon A (B)	6
Etafilcon A (C)	7

Superior region grade > 0

Group	Value	95% CI
Etafilcon A (A)	7
Etafilcon A (B)	5
Etafilcon A (C)	3

Temporal region grade > 0

Group	Value	95% CI
Etafilcon A (A)	8
Etafilcon A (B)	3
Etafilcon A (C)	5

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Subjects

Serious: 1/95 (1%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	All Subjects
Appendicitis	Gastrointestinal disorders	—

Most-reported serious reactions: Appendicitis.

Data from ClinicalTrials.gov NCT01180777 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

Publications & conference data

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