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NCT03632083

A Range of Contact Lenses and Care System Combinations

Completed NA Results posted Last updated 24 August 2020
What this trial tests

NA trial testing Hy-Care Contact Lens Solution in Contact Lens Solutions in 28 participants. Completed in 12 December 2018.

Timeline
12 September 2018
Primary endpoint
23 October 2018
12 December 2018

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment28
Start date12 September 2018
Primary completion23 October 2018
Estimated completion12 December 2018
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision, Inc.

Who can join

18 and older, any sex, with Contact Lens Solutions. 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.

Biomicroscopy - Conjuctival Hyperaemia Primary · Baseline (before lens insertion)

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.95± 0.22
Hy-Care Contact Lens Solution - Fanfilcon A0.94± 0.23
Lite Contact Lens Solution - Comfilcon A0.91± 0.23
Lite Contact Lens Solution - Fanfilcon A0.91± 0.21
Biomicroscopy - Conjuctival Hyperaemia Primary · 2 hours

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A1.01± 0.21
Hy-Care Contact Lens Solution - Fanfilcon A1.01± 0.21
Lite Contact Lens Solution - Comfilcon A0.99± 0.24
Lite Contact Lens Solution - Fanfilcon A0.99± 0.25
Biomicroscopy - Limbal Hyperaemia Primary · Baseline (before contact lens insertion)

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.86± 0.26
Hy-Care Contact Lens Solution - Fanfilcon A0.85± 0.28
Lite Contact Lens Solution - Comfilcon A0.76± 0.30
Lite Contact Lens Solution - Fanfilcon A0.76± 0.28
Biomicroscopy - Limbal Hyperaemia Primary · 2 hours

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.90± 0.27
Hy-Care Contact Lens Solution - Fanfilcon A0.90± 0.28
Lite Contact Lens Solution - Comfilcon A0.81± 0.29
Lite Contact Lens Solution - Fanfilcon A0.81± 0.31
Biomicroscopy - Corneal Vascularisation Primary · Baseline (before lens insertion)

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.08± 0.15
Hy-Care Contact Lens Solution - Fanfilcon A0.08± 0.15
Lite Contact Lens Solution - Comfilcon A0.06± 0.12
Lite Contact Lens Solution - Fanfilcon A0.06± 0.12
Biomicroscopy - Corneal Vascularisation Primary · 2 hours

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.09± 0.17
Hy-Care Contact Lens Solution - Fanfilcon A0.09± 0.17
Lite Contact Lens Solution - Comfilcon A0.06± 0.12
Lite Contact Lens Solution - Fanfilcon A0.05± 0.12
Biomicroscopy - Microcysts Primary · Baseline (before lens insertion)

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.00± 0.00
Hy-Care Contact Lens Solution - Fanfilcon A0.00± 0.00
Lite Contact Lens Solution - Comfilcon A0.00± 0.00
Lite Contact Lens Solution - Fanfilcon A0.00± 0.00
Biomicroscopy - Microcysts Primary · 2 hours

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.00± 0.00
Hy-Care Contact Lens Solution - Fanfilcon A0.00± 0.00
Lite Contact Lens Solution - Comfilcon A0.00± 0.00
Lite Contact Lens Solution - Fanfilcon A0.00± 0.00
Biomicroscopy - Oedema Primary · Baseline (before lens insertion)

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.00± 0.00
Hy-Care Contact Lens Solution - Fanfilcon A0.00± 0.00
Lite Contact Lens Solution - Comfilcon A0.00± 0.00
Lite Contact Lens Solution - Fanfilcon A0.00± 0.00
Biomicroscopy - Oedema Primary · 2 hours

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.00± 0.00
Hy-Care Contact Lens Solution - Fanfilcon A0.00± 0.00
Lite Contact Lens Solution - Comfilcon A0.00± 0.00
Lite Contact Lens Solution - Fanfilcon A0.00± 0.00
Biomicroscopy - Conjunctival Staining Primary · Baseline (before lens insertion)

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A0.30± 0.32
Hy-Care Contact Lens Solution - Fanfilcon A0.34± 0.32
Lite Contact Lens Solution - Comfilcon A0.33± 0.30
Lite Contact Lens Solution - Fanfilcon A0.33± 0.32
Biomicroscopy - Conjunctival Staining Primary · 2 hours

Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

GroupValue95% CI
Hy-Care Contact Lens Solution - Comfilcon A1.00± 0.50
Hy-Care Contact Lens Solution - Fanfilcon A0.91± 0.43
Lite Contact Lens Solution - Comfilcon A1.16± 0.41
Lite Contact Lens Solution - Fanfilcon A1.09± 0.44

Sponsor's own description

The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.

Publications & conference data

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

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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/NCT03632083.

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