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NCT03360110

Comparison of New Contact Lens With Current Marketed Lens

Completed NA Results posted Last updated 2 September 2020
What this trial tests

NA trial testing Phoebe test lens in Myopia in 53 participants. Completed in 15 December 2017.

Timeline
6 November 2017
Primary endpoint
15 December 2017
15 December 2017

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment53
Start date6 November 2017
Primary completion15 December 2017
Estimated completion15 December 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision, Inc.

Who can join

Adults 18 to 35, 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.

Corneal Staining Extent Primary · Baseline

Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).

GroupValue95% CI
Phoebe Test Lens0.04± 0.09
Stenfilcon A Control Lens0.04± 0.09
Corneal Staining Extent Primary · Day 3

Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).

GroupValue95% CI
Phoebe Test Lens0.07± 0.13
Stenfilcon A Control Lens0.07± 0.12
Conjunctival Staining Score Primary · Baseline

Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

GroupValue95% CI
Phoebe Test Lens0.18± 0.21
Stenfilcon A Control Lens0.18± 0.21
Conjunctival Staining Score Primary · Day 3

Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

GroupValue95% CI
Phoebe Test Lens0.26± 0.26
Stenfilcon A Control Lens0.29± 0.28
Palpebral Hyperemia on Upper Lid Primary · Baseline

Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Upper Lid0.96± 0.39
Stenfilcon A Control Lens: Upper Lid0.96± 0.39
Palpebral Hyperemia on Upper Lid Primary · Day 3

Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Upper Lid1.05± 0.40
Stenfilcon A Control Lens: Upper Lid1.06± 0.38
Palpebral Hyperemia on Lower Lid Primary · Baseline

Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Lower Lid0.96± 0.39
Stenfilcon A Control Lens: Lower Lid0.96± 0.39
Palpebral Hyperemia on Lower Lid Primary · Day 3

Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Lower Lid1.05± 0.40
Stenfilcon A Control Lens: Lower Lid1.06± 0.38
Palpebral Roughness Grade - Upper Lid Primary · Baseline

Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Upper Lid1.09± 0.51
Stenfilcon A Control Lens: Upper Lid1.09± 0.51
Palpebral Roughness Grade - Upper Lid Primary · Day 3

Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Upper Lid1.26± 0.53
Stenfilcon A Control Lens: Upper Lid1.20± 0.46
Palpebral Roughness Grade - Lower Lid Primary · Baseline

Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Lower Lid1.07± 0.50
Stenfilcon A Control Lens: Lower Lid1.07± 0.50
Palpebral Roughness Grade - Lower Lid Primary · Day 3

Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

GroupValue95% CI
Phoebe Test Lens: Lower Lid1.23± 0.52
Stenfilcon A Control Lens: Lower Lid1.20± 0.46

Sponsor's own description

The purpose of this study is to validate the clinical performance of a new contact lens design.

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 recruiting trials for Myopia

Currently open trials in the same condition.

Other CooperVision, 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/NCT03360110.

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