Corneal StainingNCT02251561
Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan
A study testing FID 109182, Opti-Free Plus and Senofilcon A contact lens in people with Corneal Staining, run by Alcon Research.
Trial summary
The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Corneal Staining
- What is being tested?
- FID 109182, Opti-Free Plus and Senofilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Soft contact lenses habitual wearer, both eyes.
- Voluntarily sign Informed Consent.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
- Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
- Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
- Corneal staining greater than Grade 1 at baseline.
- Pregnant, lactating, or intend to become pregnant during study period.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®
The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.
- Conditions
- Corneal Staining
- Being tested
- FID 109182, Opti-Free Plus, Senofilcon A contact lens
- Keywords
- contact lenses, contact lens solution, corneal staining, fluorescein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 109182Device
Also called Opti-Free III
Investigational multipurpose contact lens cleaning and disinfecting solution
Opti-Free PlusDevice
Also called Opti-Free Plus®
Commercially available multipurpose contact lens cleaning and disinfecting solution
Senofilcon A contact lensDevice
Also called Acuvue® Oasys®
Commercially available silicone hydrogel contact lens
| Study group | Role | What they receive |
|---|---|---|
| FID 109182 | Experimental | Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours Receives: Device: FID 109182; Device: Senofilcon A contact lens |
| Opti-Free Plus | Active comparator | Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours Receives: Device: Opti-Free Plus; Device: Senofilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
Measured: Day 1, after 2 hours of wear
Secondary outcomes (1)
Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.
Measured: Day 1, after 2 hours of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal StainingStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsunemitsu Senta, Study director, Alcon Japan, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251561
- Sponsor's protocol ID
- CVKK2013-01
- Status last verified
- Jun 2015
- First submitted
- 25 Sep 2014
- Last updated
- 10 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®
- ClinicalTrials.gov ID
- NCT02251561
- Acronym / sponsor ID
- CVKK2013-01
- Conditions
- Corneal Staining
- Keywords
- contact lenses, contact lens solution, corneal staining, fluorescein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Posted 10 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 109182 | Experimental | Device: FID 109182, Device: Senofilcon A contact lensSenofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours |
| Opti-Free Plus | Active comparator | Device: Opti-Free Plus, Device: Senofilcon A contact lensSenofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Soft contact lenses habitual wearer, both eyes.
- Voluntarily sign Informed Consent.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
- Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
- Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
- Corneal staining greater than Grade 1 at baseline.
- Pregnant, lactating, or intend to become pregnant during study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FID 109182Also: Opti-Free IIIInvestigational multipurpose contact lens cleaning and disinfecting solution | Device | FID 109182 |
| Opti-Free PlusAlso: Opti-Free Plus®Commercially available multipurpose contact lens cleaning and disinfecting solution | Device | Opti-Free Plus |
| Senofilcon A contact lensAlso: Acuvue® Oasys®Commercially available silicone hydrogel contact lens | Device | FID 109182, Opti-Free Plus |
Primary outcome
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
Time frame: Day 1, after 2 hours of wear
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
1 secondary outcome
Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
Time frame: Day 1, after 2 hours of wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsunemitsu Senta study director
Alcon Japan, Ltd.
Questions about this trial
What is this clinical trial studying?
A study testing FID 109182, Opti-Free Plus and Senofilcon A contact lens in people with Corneal Staining, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein (time frame: Day 1, after 2 hours of wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.