Trial Outcomes & Findings for A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand (NCT NCT01335750)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Baseline, 2 Hour Period, 4 Hour Period

Results posted on

2020-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Multipurpose Solution To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multipurpose Solution n=32 Participants To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
Age, Continuous	32 Years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 Hour Period, 4 Hour Period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Multipurpose Solution #1 n=32 Participants B\&L Renu Fresh Multipurpose Solution	Multipurpose Solution #2 n=32 Participants Optifree Replenish Multipurpose Solution	Multipurpose Solution #3 n=32 Participants Ciba ClearCare Multipurpose Solution	Multipurpose Solution #4 n=32 Participants Saline Multipurpose Solution
Corneal Staining Severity Baseline	0.01 units on a scale Interval 0.0 to 4.0	0.01 units on a scale Interval 0.0 to 4.0	0.02 units on a scale Interval 0.0 to 4.0	0.01 units on a scale Interval 0.0 to 4.0
Corneal Staining Severity 2 Hour Period	0.10 units on a scale Interval 0.0 to 4.0	0.76 units on a scale Interval 0.0 to 4.0	0.05 units on a scale Interval 0.0 to 4.0	0.06 units on a scale Interval 0.0 to 4.0
Corneal Staining Severity 3 Hour Period	0.06 units on a scale Interval 0.0 to 4.0	0.59 units on a scale Interval 0.0 to 4.0	0.06 units on a scale Interval 0.0 to 4.0	0.06 units on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: Baseline, 2 Hour Period, 4 Hour Period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Multipurpose Solution #1 n=32 Participants B\&L Renu Fresh Multipurpose Solution	Multipurpose Solution #2 n=32 Participants Optifree Replenish Multipurpose Solution	Multipurpose Solution #3 n=32 Participants Ciba ClearCare Multipurpose Solution	Multipurpose Solution #4 n=32 Participants Saline Multipurpose Solution
Corneal Staining Area Baseline	0.1 units on a scale Standard Deviation 0	0.1 units on a scale Standard Deviation 0	0.2 units on a scale Standard Deviation 0	0.1 units on a scale Standard Deviation 0
Corneal Staining Area 2 Hour Period	1.2 units on a scale Standard Deviation 2.1	17.1 units on a scale Standard Deviation 13.2	0.6 units on a scale Standard Deviation 1.3	0.7 units on a scale Standard Deviation 1.3
Corneal Staining Area 3 Hour Period	0.9 units on a scale Standard Deviation 1.6	10.3 units on a scale Standard Deviation 11.4	0.8 units on a scale Standard Deviation 1.4	0.8 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

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

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

Outcome measures

Outcome measures
Measure	Multipurpose Solution #1 n=32 Participants B\&L Renu Fresh Multipurpose Solution	Multipurpose Solution #2 n=32 Participants Optifree Replenish Multipurpose Solution	Multipurpose Solution #3 n=32 Participants Ciba ClearCare Multipurpose Solution	Multipurpose Solution #4 n=32 Participants Saline Multipurpose Solution
Subjective Comfort Baseline	82.9 units on a scale Standard Deviation 15.0	80.3 units on a scale Standard Deviation 14.6	84.8 units on a scale Standard Deviation 13.4	84.7 units on a scale Standard Deviation 14.0
Subjective Comfort 2 Hour Period	83.2 units on a scale Standard Deviation 13.9	81.6 units on a scale Standard Deviation 15.8	85.6 units on a scale Standard Deviation 13.9	83.7 units on a scale Standard Deviation 14.5
Subjective Comfort 4 Hour Period	80.5 units on a scale Standard Deviation 14.7	78.0 units on a scale Standard Deviation 18.7	83.4 units on a scale Standard Deviation 16.3	85.3 units on a scale Standard Deviation 14.5

SECONDARY outcome

Timeframe: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours

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

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

Outcome measures

Outcome measures
Measure	Multipurpose Solution #1 n=32 Participants B\&L Renu Fresh Multipurpose Solution	Multipurpose Solution #2 n=32 Participants Optifree Replenish Multipurpose Solution	Multipurpose Solution #3 n=32 Participants Ciba ClearCare Multipurpose Solution	Multipurpose Solution #4 n=32 Participants Saline Multipurpose Solution
Subjective Dryness Baseline	84.9 units on a scale Standard Deviation 14.0	81.1 units on a scale Standard Deviation 15.3	85.0 units on a scale Standard Deviation 14.4	85.1 units on a scale Standard Deviation 13.1
Subjective Dryness 2 Hour Period	82.8 units on a scale Standard Deviation 13.2	76.9 units on a scale Standard Deviation 19.4	83.0 units on a scale Standard Deviation 15.3	81.7 units on a scale Standard Deviation 16.6
Subjective Dryness 4 Hour Period	81.4 units on a scale Standard Deviation 15.3	76.2 units on a scale Standard Deviation 20.1	81.9 units on a scale Standard Deviation 16.8	83.1 units on a scale Standard Deviation 17.4

Adverse Events

Multipurpose Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary Andrasko, MS

Erdy/Searcy Group

Phone: (614) 459-3363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place