CompletedNCT01335750Updated Jul 28, 2020Results posted

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

An interventional study of Multipurpose Solution #1 and Multipurpose Solution #2 in Corneal Staining, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Corneal Staining

Keywords

corneal staining

In context

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.

Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 32 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Baseline, 2 Hour Period, 4 Hour Period

Secondary outcomes

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

Results

Posted Mar 5, 2013

Participant flow

Participant flow — Overall Study
Milestone	Multipurpose Solution
Started	32
Completed	32
Not completed	0

Outcome measures

SecondarySubjective Comfort

Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)

Time frame:: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Reported as:: Mean · units on a scale

Subjective Comfort
units on a scale	Multipurpose Solution #1	Multipurpose Solution #2	Multipurpose Solution #3	Multipurpose Solution #4
Baseline	82.9 ± 15.0	80.3 ± 14.6	84.8 ± 13.4	84.7 ± 14.0
2 Hour Period	83.2 ± 13.9	81.6 ± 15.8	85.6 ± 13.9	83.7 ± 14.5
4 Hour Period	80.5 ± 14.7	78.0 ± 18.7	83.4 ± 16.3	85.3 ± 14.5

SecondarySubjective Dryness

Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)

Time frame:: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Reported as:: Mean · units on a scale

Subjective Dryness
units on a scale	Multipurpose Solution #1	Multipurpose Solution #2	Multipurpose Solution #3	Multipurpose Solution #4
Baseline	84.9 ± 14.0	81.1 ± 15.3	85.0 ± 14.4	85.1 ± 13.1
2 Hour Period	82.8 ± 13.2	76.9 ± 19.4	83.0 ± 15.3	81.7 ± 16.6
4 Hour Period	81.4 ± 15.3	76.2 ± 20.1	81.9 ± 16.8	83.1 ± 17.4

PrimaryCorneal 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.

Time frame:: Baseline, 2 Hour Period, 4 Hour Period
Reported as:: Mean · units on a scale

Corneal Staining Severity
units on a scale	Mutlipurpose Solution #1	Multipurpose Solution #2	Multipurpose Solution #3	Multipurpose Solution #4
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)

PrimaryCorneal 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.

Time frame:: Baseline, 2 Hour Period, 4 Hour Period
Reported as:: Mean · units on a scale

Corneal Staining Area
units on a scale	Multipurpose Solution #1	Multipurpose Solution #2	Multipurpose Solution #3	Multipurpose Solution #4
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

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Multipurpose Solution	—	0/32 (0%)	0/32 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Multipurpose Solution
Mean	32 (23 to 62)

Sex: Female, Male
Sex: Female, Male(Participants)	Multipurpose Solution
Female	14
Male	18

Study locations

1 site

Erdey/Searcy Eye Group
Columbus, Ohio 43213, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01335750
Lead sponsor: CooperVision International Limited (CVIL)
Responsible party: Sponsor
First posted: Apr 14, 2011
Start date: Aug 2010
Primary completion: Sep 2010
Completion: Sep 2010
Results posted: Mar 5, 2013
Last update: Jul 28, 2020

Study contacts

Gary Andrasko, OD, MS

principal investigator · Erdey/Searcy Eye Group

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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