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 ExtentPrimary· 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).
Group
Value
95% CI
Phoebe Test Lens
0.04
± 0.09
Stenfilcon A Control Lens
0.04
± 0.09
Corneal Staining ExtentPrimary· 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).
Group
Value
95% CI
Phoebe Test Lens
0.07
± 0.13
Stenfilcon A Control Lens
0.07
± 0.12
Conjunctival Staining ScorePrimary· Baseline
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Group
Value
95% CI
Phoebe Test Lens
0.18
± 0.21
Stenfilcon A Control Lens
0.18
± 0.21
Conjunctival Staining ScorePrimary· Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Group
Value
95% CI
Phoebe Test Lens
0.26
± 0.26
Stenfilcon A Control Lens
0.29
± 0.28
Palpebral Hyperemia on Upper LidPrimary· Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Group
Value
95% CI
Phoebe Test Lens: Upper Lid
0.96
± 0.39
Stenfilcon A Control Lens: Upper Lid
0.96
± 0.39
Palpebral Hyperemia on Upper LidPrimary· Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Group
Value
95% CI
Phoebe Test Lens: Upper Lid
1.05
± 0.40
Stenfilcon A Control Lens: Upper Lid
1.06
± 0.38
Palpebral Hyperemia on Lower LidPrimary· Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Group
Value
95% CI
Phoebe Test Lens: Lower Lid
0.96
± 0.39
Stenfilcon A Control Lens: Lower Lid
0.96
± 0.39
Palpebral Hyperemia on Lower LidPrimary· Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CooperVision, Inc.
Last refreshed: 2 September 2020
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.