Corneal StainingNCT01335750

A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

A study testing Multipurpose Solution #1, Multipurpose Solution #2 and Mutlipurpose Solution #3 in people with Corneal Staining, run by CooperVision, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Corneal Staining
What is being tested?: Multipurpose Solution #1, Multipurpose Solution #2 and Mutlipurpose Solution #3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Sep 2010
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Informed Consent and HIPAA document read, signed, and dated.
Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Who cannot join

History of hypersensitivity
Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
One functional eye or a monofit eye
Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period

Show all 12Show fewer

Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
Abnormal lenticular opacity in the visual axis of the lens in either eye
Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
Pregnant or lactating females

Trial locations and contacts

1 site in 1 country.

United States1 site

Erdey/Searcy Eye Group
Columbus, Ohio, 43213

Other trials in United States

About this study

Conditions: Corneal Staining
Being tested: Multipurpose Solution #1, Multipurpose Solution #2, Mutlipurpose Solution #3, Multipurpose Solution #4
Keywords: corneal staining

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multipurpose Solution #1Other
B\&L Renu Fresh Multipurpose Solution
Multipurpose Solution #2Other
Optifree Replenish Multipurpose Solution
Mutlipurpose Solution #3Other
Ciba ClearCare Multipurpose Solution
Multipurpose Solution #4Other
Saline Solution

Study groups in NCT01335750
Study group	Role	What they receive
Multipurpose Solution #1	Experimental	B\&L Renu Fresh Multipurpose Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4
Multipurpose Solution #2	Experimental	OptiFree Replenish Multipurpose Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4
Multipurpose Solution #3	Experimental	Ciba ClearCare Multipurpose Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4
Multipurpose Solution #4	Active comparator	Saline Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4

What is being measured

The primary outcome is the main question the study is designed to answer.

Corneal Staining Severity
Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Measured: Baseline, 2 Hour Period, 4 Hour Period
Corneal Staining Area
Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.
Measured: Baseline, 2 Hour Period, 4 Hour Period

Secondary outcomes (2)

Subjective Comfort
Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)
Measured: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Subjective Dryness
Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)
Measured: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Sep 2010

First posted14 Apr 2011 (estimated)
Study startAug 2010
Primary completionSep 2010
Study completionSep 2010

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.
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
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01335750
Sponsor's protocol ID: CV-09-64, Sterling IRB 3576
Status last verified: Jul 2020
First submitted: 7 Oct 2010
Last updated: 28 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction (MGD)
Not yet recruiting
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
Corneal Injury, Exposure Keratopathy
Enrolling by invitationPhase 4
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
Dry Eye Disease (DED), Tear Break-Up Time

All Corneal Staining trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
ClinicalTrials.gov ID: NCT01335750
Acronym / sponsor ID: CV-09-64, Sterling IRB 3576
Conditions: Corneal Staining
Keywords: corneal staining
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 14 Apr 2011 (estimated)
Results: Posted 5 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Multipurpose Solution #1	Experimental	Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4B\&L Renu Fresh Multipurpose Solution
Multipurpose Solution #2	Experimental	Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4OptiFree Replenish Multipurpose Solution
Multipurpose Solution #3	Experimental	Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4Ciba ClearCare Multipurpose Solution
Multipurpose Solution #4	Active comparator	Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4Saline Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Informed Consent and HIPAA document read, signed, and dated.
Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Key exclusion criteria (12 listed)

History of hypersensitivity
Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
One functional eye or a monofit eye
Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each 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
Multipurpose Solution #1B\&L Renu Fresh Multipurpose Solution	Other	Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4
Multipurpose Solution #2Optifree Replenish Multipurpose Solution	Other	Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4
Mutlipurpose Solution #3Ciba ClearCare Multipurpose Solution	Other	Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4
Multipurpose Solution #4Saline Solution	Other	Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4

Primary outcome

Corneal Staining Severity
Time frame: Baseline, 2 Hour Period, 4 Hour Period
Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Corneal Staining Area
Time frame: Baseline, 2 Hour Period, 4 Hour Period
Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.

2 secondary outcomes

Subjective Comfort
Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Subjective Dryness
Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

Results and safety

Results posted to the registry on 5 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multipurpose Solution	32	32

Primary outcome: Corneal Staining Severity

Time frame: Baseline, 2 Hour Period, 4 Hour Period. Mean (Full Range). Unit: units on a scale

Measure	Mutlipurpose Solution #1 n = 32	Multipurpose Solution #2 n = 32	Multipurpose Solution #3 n = 32	Multipurpose Solution #4 n = 32
Baseline	0.01 (0 to 4)	0.01 (0 to 4)	0.02 (0 to 4)	0.01 (0 to 4)
2 Hour Period	0.10 (0 to 4)	0.76 (0 to 4)	0.05 (0 to 4)	0.06 (0 to 4)
3 Hour Period	0.06 (0 to 4)	0.59 (0 to 4)	0.06 (0 to 4)	0.06 (0 to 4)

Population analysed: Severity of staining was recorded for each region using a scale of 0-none to 4-patch \>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.

Primary outcome: Corneal Staining Area

Time frame: Baseline, 2 Hour Period, 4 Hour Period. Mean (Standard Deviation). Unit: units on a scale

Measure	Multipurpose Solution #1 n = 32	Multipurpose Solution #2 n = 32	Multipurpose Solution #3 n = 32	Multipurpose Solution #4 n = 32
Baseline	0.1 (0)	0.1 (0)	0.2 (0)	0.1 (0)
2 Hour Period	1.2 (2.1)	17.1 (13.2)	0.6 (1.3)	0.7 (1.3)
3 Hour Period	0.9 (1.6)	10.3 (11.4)	0.8 (1.4)	0.8 (1.7)

Population analysed: Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multipurpose Solution	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for more information about similar studiesLink provided by the sponsor.

Related trials for Corneal Staining

Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction (MGD)
Not yet recruiting
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
Corneal Injury, Exposure Keratopathy
Enrolling by invitationPhase 4
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
Dry Eye Disease (DED), Tear Break-Up Time

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.

Gary Andrasko, OD, MS principal investigator

Erdey/Searcy Eye Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multipurpose Solution #1, Multipurpose Solution #2 and Mutlipurpose Solution #3 in people with Corneal Staining, run by CooperVision, Inc. 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 3 inclusion and 12 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 28 Jul 2020. 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 5 Mar 2013). 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?

Corneal Staining Severity (time frame: Baseline, 2 Hour Period, 4 Hour Period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01335750.

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 28 Jul 2020.