Clinical Optical Research Lab (CORL)
Bloomington, Indiana, 47405, United States
NCT Number: NCT03360110
The purpose of this study is to validate the clinical performance of a new contact lens design.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Bloomington, Indiana, 47405, United States
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
Exclusion criteria
A person will be excluded from the study if he/she:
Daily disposable contact lens
Other names: Test Lens, Phoebe Contact Lens
Daily disposable contact lens
Other names: MyDay daily disposable contact lens
Time frame: 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).
Time frame: 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).
Time frame: Baseline
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Time frame: Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Time frame: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time frame: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time frame: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time frame: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time frame: Baseline (at lens dispense)
Distance visual acuity recorded in logMAR.
Time frame: Day 3
Distance visual acuity recorded in logMAR.
Time frame: Baseline (at dispense)
Near visual acuity recorded in logMAR
Time frame: Day 3
Near visual acuity recorded in logMAR
Time frame: Baseline (at dispense)
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Time frame: Day 3
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
CooperVision, Inc.
Industry
Clinical Validation Study of Phoebe Lens
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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