An interventional study of Lens A (fanfilcon A) and Lens B (lotrafilcon B) in Myopia and Hyperopia, sponsored by CooperVision, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by CooperVision, Inc. (part of CooperCompanies) · Not applicable, Interventional, and Treatment
Among 22 studies in Myopia by CooperVision, Inc. — none open to participants now, 2 under way, none of them phase 3. Myopia · CooperVision, Inc..
Among the 22 studies in Myopia by CooperVision, Inc., this one is the 7th largest by enrollment of the 21 interventional ones that give a count, is one of 6 that started in 2023, is one of 21 with no phase, and was the 15th registered.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
Browse Myopia studies →None of the 22 studies in Myopia by CooperVision, Inc. is open now.
Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.
This study: 18 Years to 39 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 6 started in 2023.
This study's enrollment of 53 is below the median of 78 across 923 interventional studies indexed under Myopia.
Median enrollment 45 across the 21 interventional studies, 53 across the 1 observational. Of the 20 that completed or were terminated, 18 (90%) have results posted.
This tab as a report to print or save as PDF → With an account.
CooperVision, Inc. is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 31 (94%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Myopia by CooperVision, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Habitually wore spherical soft contact lenses, for the past 3 months minimum:
It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants wore Lens A for one month and then Lens B for one month.
Device: Lens A (fanfilcon A) · Device: Lens B (lotrafilcon B)
Participants wore Lens B one month and then Lens A for one month.
Device: Lens A (fanfilcon A) · Device: Lens B (lotrafilcon B)
Daily wear for one month
Daily wear for one month
Lens Handling on Removal
Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.
Time frame: Day 27
| Milestone | Lens A, Then Lens B | Lens B, Then Lens A |
|---|---|---|
| Started | 25 | 28 |
| Completed | 24 | 26 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Enrolled outside the study inclusion/exclusion criteria and was discontinued early | 1 | 1 |
| Milestone | Lens A, Then Lens B | Lens B, Then Lens A |
|---|---|---|
| Started | 24 | 26 |
| Completed | 24 | 26 |
| Not completed | 0 | 0 |
Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.
| score on a scale | Lens A | Lens B |
|---|---|---|
| Lens Handling on Removal | 84 ± 21 | 89 ± 17 |
Collected over The duration of the clinical trial, approximately 2-3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lens A | 0/50 (0%) | 0/50 (0%) | 5/50 (10%) |
| Lens B | 0/50 (0%) | 0/50 (0%) | 4/50 (8%) |
| Event | Lens A | Lens B |
|---|---|---|
| Ocular discomfort,Eye disorders | 3/50 | 0/50 |
| Viral conjunctivitisEye disorders | 0/50 | 1/50 |
| Asymptomatic corneal infiltrate eventEye disorders | 1/50 | 1/50 |
| Lower lid small chalazionEye disorders | 0/50 | 1/50 |
| Nasal upper lid papillomaEye disorders | 0/50 | 1/50 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 1/50 | 0/50 |
| Age, Continuous(years) | Total Study Population |
|---|---|
| Mean | 28.2 ± 6.0 |
| Sex: Female, Male(Participants) | Total Study Population |
|---|---|
| Female | 37 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | Total Study Population |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2023 to primary completion in Apr 2024, 4 months.
Results were first posted in Jul 2024, 3 months after primary completion.
Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's 4 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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