An interventional study of Lotrafilcon B contact lenses with added wetting agent and Samfilcon A contact lenses in Refractive Errors, Myopia and Hypermetropia, sponsored by Alcon, a Novartis Company. Completed at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's enrollment of 323 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Alcon left Novartis.
Counted across the registry records on this site, refreshed daily.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
Device: Lotrafilcon B contact lenses with added wetting agent · Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent · Device: Hydrogen peroxide-based contact lens solution with added wetting agent
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
Device: Samfilcon A contact lenses · Device: Senofilcon C contact lenses · Device: Senofilcon A contact lenses · Device: Comfilcon A contact lenses · Device: Habitual Multi-Purpose Solution (HMPS)
Silicone hydrogel contact lenses
Also known as: AIR OPTIX® plus HYDRAGLYDE® (AOHG)
Habitual silicone hydrogel contact lenses
Also known as: Bausch + Lomb ULTRA™ (Ultra)
Multi-purpose disinfecting solution for contact lens care
Also known as: OPTI-FREE® PureMoist® (OFPM)
Solution for contact lens cleaning and disinfecting
Also known as: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
Habitual silicone hydrogel contact lenses
Also known as: Johnson & Johnson ACUVUE® VITA™ (Vita)
Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
Also known as: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)
Habitual silicone hydrogel contact lenses
Also known as: CooperVision® Biofinity® (Biofinity)
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
Ex Vivo Total Cholesterol Uptake at Day 30
The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.
Time frame: Day 30
Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).
| Milestone | AOHG/CCP | AOHG/OFPM | Biofinity/HMPS | Vita/HMPS | Ultra/HMPS | Oasys/HMPS |
|---|---|---|---|---|---|---|
| Started | 60 | 64 | 34 | 25 | 23 | 46 |
| Treated | 58 | 65 | 35 | 24 | 23 | 47 |
| Completed | 54 | 63 | 34 | 24 | 22 | 46 |
| Not completed | 6 | 1 | 0 | 1 | 1 | 0 |
| Withdrew: Adverse event | 3 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 0 | 0 |
The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.
| μg | AOHG/CCP | AOHG/OFPM | Biofinity/HMPS | Vita/HMPS | Ultra/HMPS | Oasys/HMPS |
|---|---|---|---|---|---|---|
| Ex Vivo Total Cholesterol Uptake at Day 30 | 0.28 ± 0.18 | 0.28 ± 0.48 | 2.17 ± 1.47 | 4.18 ± 3.25 | 2.07 ± 1.48 | 2.19 ± 2.69 |
Collected over Lens insertion (Day 1) through study completion, an average of 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AOHG/CCP Ocular | 0/116 (0%) | 0/116 (0%) | 0/116 (0%) |
| AOHG/CCP Nonocular | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
| AOHG/OFPM Ocular | 0/130 (0%) | 0/130 (0%) | 0/130 (0%) |
| AOHG/OFPM Nonocular | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Habitual SiHy/MPS Ocular | 0/258 (0%) | 0/258 (0%) | 0/258 (0%) |
| Habitual SiHy/MPS Nonocular | 0/129 (0%) | 0/129 (0%) | 0/129 (0%) |
This analysis population includes all randomized and exposed to a study lens on Day 1 or a study regimen (lens and lens care system (LCS)) thereafter (Full Analysis Set).
| Age, Continuous(years) | AOHG/CCP | AOHG/OFPM | Biofinity/HMPS | Vita/HMPS | Ultra/HMPS | Oasys/HMPS | Total |
|---|---|---|---|---|---|---|---|
| Mean | 27.7 ± 7.0 | 27.8 ± 6.0 | 28.2 ± 5.9 | 28.2 ± 5.7 | 28.8 ± 7.2 | 30.4 ± 8.2 | 28.4 ± 6.8 |
| Sex: Female, Male(Participants) | AOHG/CCP | AOHG/OFPM | Biofinity/HMPS | Vita/HMPS | Ultra/HMPS | Oasys/HMPS | Total |
|---|---|---|---|---|---|---|---|
| Female | 39 | 49 | 22 | 17 | 17 | 35 | 179 |
| Male | 21 | 15 | 12 | 8 | 6 | 11 | 73 |
| Ethnicity (NIH/OMB)(Participants) | AOHG/CCP | AOHG/OFPM | Biofinity/HMPS | Vita/HMPS | Ultra/HMPS | Oasys/HMPS | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 1 | 1 | 1 | 1 | 3 | 12 |
| Not Hispanic or Latino | 54 | 62 | 33 | 24 | 22 | 43 | 238 |
| Unknown or Not Reported | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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