Conjunctival StainingNCT00799422
Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients
A study testing Complete Easy Rub, ReNu MultiPlus and Clear Care in people with Conjunctival Staining, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctival Staining
- What is being tested?
- Complete Easy Rub, ReNu MultiPlus and Clear Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
- Read, sign, and date informed consent/HIPAA document;
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
- Willing and able to discontinue contact lens wear when requested during the study;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Evidence or history of ocular disease or pathology;
- One functional eye or a monofit lens;
- Use of concomitant topical ocular prescription or over-the-counter ocular medications;
- History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients
The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.
- Conditions
- Conjunctival Staining
- Being tested
- Complete Easy Rub, ReNu MultiPlus, Clear Care, Contact lenses
- Keywords
- Conjunctival Staining, lens parameters, lens fit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Easy RubDevice
Also called Complete® Easy Rub®
Commercially marketed contact lens solution for contact lens care
ReNu MultiPlusDevice
Also called ReNu MultiPlus®
Commercially marketed contact lens solution for contact lens care
Clear CareDevice
Also called Clear Care®
Commercially marketed contact lens solution for contact lens care
Contact lensesDevice
Also called ACUVUE® OASYS®
Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.
| Study group | Role | What they receive |
|---|---|---|
| ReNu MultiPlus | Active comparator | ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. Receives: Device: ReNu MultiPlus; Device: Contact lenses |
| Complete Easy Rub | Active comparator | Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. Receives: Device: Complete Easy Rub; Device: Contact lenses |
| Clear Care | Active comparator | Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. Receives: Device: Clear Care; Device: Contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Circumlimbal Conjunctival Staining Score
Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
Measured: 1 week
Secondary outcomes (2)
Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week
Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.
Measured: Dispense (Day 0), 1 week
Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week
Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.
Measured: Dispense (Day 0), 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Conjunctival 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison Ramsey, O.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799422
- Sponsor's protocol ID
- M-08-02
- Status last verified
- Nov 2012
- First submitted
- 25 Nov 2008
- Last updated
- 16 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients
- ClinicalTrials.gov ID
- NCT00799422
- Acronym / sponsor ID
- M-08-02
- Conditions
- Conjunctival Staining
- Keywords
- Conjunctival Staining, lens parameters, lens fit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Posted 16 Nov 2012
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 was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ReNu MultiPlus | Active comparator | Device: ReNu MultiPlus, Device: Contact lensesReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. |
| Complete Easy Rub | Active comparator | Device: Complete Easy Rub, Device: Contact lensesComplete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. |
| Clear Care | Active comparator | Device: Clear Care, Device: Contact lensesClear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
- Read, sign, and date informed consent/HIPAA document;
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
- Willing and able to discontinue contact lens wear when requested during the study;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Evidence or history of ocular disease or pathology;
- One functional eye or a monofit lens;
- Use of concomitant topical ocular prescription or over-the-counter ocular medications;
- History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Complete Easy RubAlso: Complete® Easy Rub®Commercially marketed contact lens solution for contact lens care | Device | Complete Easy Rub |
| ReNu MultiPlusAlso: ReNu MultiPlus®Commercially marketed contact lens solution for contact lens care | Device | ReNu MultiPlus |
| Clear CareAlso: Clear Care®Commercially marketed contact lens solution for contact lens care | Device | Clear Care |
| Contact lensesAlso: ACUVUE® OASYS®Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week. | Device | Clear Care, Complete Easy Rub, ReNu MultiPlus |
Primary outcome
Mean Circumlimbal Conjunctival Staining Score
Time frame: 1 week
Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.
2 secondary outcomes
Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week
Time frame: Dispense (Day 0), 1 week
Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week
Time frame: Dispense (Day 0), 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
- 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.
Alison Ramsey, O.D. study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Easy Rub, ReNu MultiPlus and Clear Care in people with Conjunctival Staining, run by Alcon Research at 1 site in United States.
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 5 inclusion and 5 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 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 16 Nov 2012). 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?
Mean Circumlimbal Conjunctival Staining Score (time frame: 1 week). 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 16 Nov 2012.