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Home › Trials › NCT04585646 NCT04585646
A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
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Summary Quick facts Who can join Endpoints Results Publications Related trials Sources
Completed
NA
Results posted
Last updated 10 May 2022
What this trial tests
NA trial testing Orion daily disposable contact lens in Myopia in 64 participants. Completed in 31 December 2020.
Timeline
14 September 2020
Primary endpoint
31 December 2020
Quick facts
Lead sponsor CooperVision, Inc. Phase NA Status Completed Study type INTERVENTIONAL Allocation randomized Design crossover Masking double Primary purpose treatment Enrollment 64 Start date 14 September 2020 Primary completion 30 November 2020 Estimated completion 31 December 2020 Sites 1 location across United States
Drugs / interventions tested
Orion daily disposable contact lens Gemini daily disposable contact lens
Conditions studied
Myopia
Sponsor
CooperVision, Inc.
Who can join
Adults 18 to 55, 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.
Subjective Response for Vision Satisfaction
Primary
· Baseline - After 10 minutes of lens dispense
Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Very satisfied
Group Value 95% CI Orion 24 Gemini 28
Satisfied
Group Value 95% CI Orion 30 Gemini 24
Somewhat Satisfied
Group Value 95% CI Orion 4 Gemini 7
Neither
Group Value 95% CI Orion 1 Gemini 0
Somewhat Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Very Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Subjective Response for Overall Vision Satisfaction
Primary
· 2 Weeks
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Very satisfied
Group Value 95% CI Orion 26 Gemini 28
Satisfied
Group Value 95% CI Orion 22 Gemini 24
Somewhat Satisfied
Group Value 95% CI Orion 7 Gemini 5
Neither
Group Value 95% CI Orion 0 Gemini 1
Somewhat Dissatisfied
Group Value 95% CI Orion 3 Gemini 1
Dissatisfied
Group Value 95% CI Orion 1 Gemini 0
Very Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Subjective Response for Overall Vision Satisfaction
Primary
· 2 Weeks - at night
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Very satisfied
Group Value 95% CI Orion 42 Gemini 34
Satisfied
Group Value 95% CI Orion 41 Gemini 48
Somewhat Satisfied
Group Value 95% CI Orion 8 Gemini 10
Neither
Group Value 95% CI Orion 7 Gemini 3
Somewhat Dissatisfied
Group Value 95% CI Orion 2 Gemini 5
Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Very Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Subjective Response for Overall Vision Quality
Primary
· Baseline - After 10 minutes of lens dispense
Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Group Value 95% CI Orion 90 ± 8 Gemini 91 ± 9
Subjective Response for Overall Vision Quality
Primary
· 2 weeks
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Group Value 95% CI Orion 86 ± 16 Gemini 89 ± 10
Subjective Response for Overall Vision Quality
Primary
· 2 weeks - Night Driving
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Group Value 95% CI Orion 87 ± 13 Gemini 88 ± 10
Subjective Overall Comfort Satisfaction
Secondary
· Baseline - After 10 minutes of lens dispense
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Very satisfied
Group Value 95% CI Orion 32 Gemini 31
Satisfied
Group Value 95% CI Orion 20 Gemini 22
Somewhat satisfied
Group Value 95% CI Orion 7 Gemini 6
Neither
Group Value 95% CI Orion 0 Gemini 0
Somewhat Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Very Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Subjective Overall Comfort Satisfaction
Secondary
· 2 Weeks
Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Very satisfied
Group Value 95% CI Orion 22 Gemini 17
Satisfied
Group Value 95% CI Orion 25 Gemini 19
Somewhat satisfied
Group Value 95% CI Orion 6 Gemini 14
Neither
Group Value 95% CI Orion 0 Gemini 2
Somewhat Dissatisfied
Group Value 95% CI Orion 4 Gemini 4
Dissatisfied
Group Value 95% CI Orion 2 Gemini 3
Very Dissatisfied
Group Value 95% CI Orion 0 Gemini 0
Subjective Preference for Comfort
Secondary
· 2 weeks
Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Orion strongly
Group Value 95% CI Overall Study 13
Orion slightly
Group Value 95% CI Overall Study 21
No preference
Group Value 95% CI Overall Study 10
Gemini slightly
Group Value 95% CI Overall Study 7
Gemini strongly
Group Value 95% CI Overall Study 8
Lens Surface Wettability Performance
Secondary
· Baseline - After 10 minutes of lens dispense
Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)
Group Value 95% CI Orion 3.40 ± 0.36 Gemini 3.32 ± 0.40
Lens Surface Wettability Performance
Secondary
· 2 weeks
Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)
Group Value 95% CI Orion 3.31 ± 0.41 Gemini 3.40 ± 0.38
Horizontal Lens Centration
Secondary
· Baseline - After 10 minutes of lens dispense
Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value)
Group Value 95% CI Orion -0.12 ± 0.25 Gemini -0.18 ± 0.26
Sponsor's own description
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Silicone hydrogel versus hydrogel soft contact lenses for differences in patient-reported eye comfort and safety.
Haworth K, Travis D, Leslie L, Fuller D, et al ·
· 2023
· cited 10×
· PMID 37724689
· DOI 10.1002/14651858.cd014791.pub2
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT04585646 (US National Library of Medicine, public domain)Publications : Europe PMC API search by NCT ID, retrieved 10 June 2026Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by CooperVision, Inc.Last refreshed : 10 May 2022
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/NCT04585646.
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