NCT01155323

Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

Completed NA Results posted Last updated 19 June 2018

What this trial tests

NA trial testing etafilcon A in Myopia in 118 participants. Completed in 1 June 2010.

Timeline

1 March 2010

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	118
Start date	1 March 2010
Primary completion	1 June 2010
Estimated completion	1 June 2010
Sites	1 location across Singapore

Drugs / interventions tested

• etafilcon A — full drug profile →
• omafilcon A

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

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

Who can join

Adults 18 to 39, any sex, 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.

Subjective Rating of Comfort Primary · after 1 week of lens wear

This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Group	Value	95% CI
Etafilcon A	3.33	± 0.09
Omafilcon A	3.32	± 0.09

Vision Quality Primary · after 1 week of lens wear

This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Group	Value	95% CI
Etafilcon A	3.53	± 0.08
Omafilcon A	3.50	± 0.08

Subjective Rating of Handling Primary · after 1 week of lens wear

This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Group	Value	95% CI
Etafilcon A	3.48	± 0.09
Omafilcon A	3.48	± 0.09

Corneal Staining Primary · after 1 week of lens wear

Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Group	Value	95% CI
Etafilcon A	0.07	± 0.01
Omafilcon A	0.09	± 0.01

Subjective Rating of Quality Perceptions Primary · after 1 week of lens wear

This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Group	Value	95% CI
Etafilcon A	3.51	± 0.08
Omafilcon A	3.44	± 0.08

Limbal Hyperemia Primary · after 1 week of wear

This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.

Group	Value	95% CI
Etafilcon A	0.51	± 0.02
Omafilcon A	0.48	± 0.02

Sponsor's own description

This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.

Publications & conference data

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