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NCT02394808

2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population

Completed NA Results posted Last updated 19 June 2018
What this trial tests

NA trial testing senofilcon A in Visual Acuity in 54 participants. Completed in 1 September 2015.

Timeline
1 January 2015
Primary endpoint
1 September 2015
1 September 2015

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment54
Start date1 January 2015
Primary completion1 September 2015
Estimated completion1 September 2015
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 18 to 39, any sex, with Visual Acuity. 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 Overall Comfort Primary · 11 days Post fit

Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

GroupValue95% CI
Senofilcon A58.65± 18.685
Lotrafilcon B59.44± 16.458
Subjective Overall Quality of Vision Primary · 11 days post fit

Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

GroupValue95% CI
Senofilcon A55.60± 16.490
Lotrafilcon B58.71± 14.035

Sponsor's own description

The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.

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

Trials testing the same drug.

Other recruiting trials for Visual Acuity

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02394808.

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