Trial Outcomes & Findings for Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism (NCT NCT00697190)

NCT ID: NCT00697190

Last Updated: 2015-05-22

Results Overview

Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: after 6 hours of wear
• Results posted on: 2015-05-22

Participant Flow

Participant milestones

Measure	Senofilcon A/Galyfilcon A senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.	Galyfilcon A/Senofilcon A galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
First Intervention STARTED	19	20
First Intervention COMPLETED	19	20
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	18	20
Second Intervention COMPLETED	18	20
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Baseline characteristics by cohort

Measure	All Completed Subjects n=38 Participants All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
Age, Continuous	31.4 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United Kingdom	38 participants n=5 Participants

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 11 subjects that were high myopes within the total completed population of 38.

Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	1.10 Units on a scale Standard Error 0.05	1.23 Units on a scale Standard Error 0.05

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 14 subjects that were hyperopes within the total completed population of 38.

Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)	1.16 Units on a scale Standard Error 0.07	1.18 Units on a scale Standard Error 0.05

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.

Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.08 Units on a scale Standard Error 0.07	1.14 Units on a scale Standard Error 0.08

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 11 subjects that were high myopes within the total completed population of 38.

Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	0.97 Units on a scale Standard Error 0.05	1.07 Units on a scale Standard Error 0.07

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 14 subjects that were hyperopes within the total completed population of 38.

Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)	0.95 Units on a scale Standard Error 0.06	1.00 Units on a scale Standard Error 0.06

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.

Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.01 Units on a scale Standard Error 0.08	1.06 Units on a scale Standard Error 0.07

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 11 subjects that were high myopes within the total completed population of 38.

Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	0.40 Units on a scale Standard Error 0.07	0.22 Units on a scale Standard Error 0.05

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 14 subjects that were hyperopes within the total completed population of 38.

Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)	0.19 Units on a scale Standard Error 0.07	0.28 Units on a scale Standard Error 0.09

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.

Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	0.35 Units on a scale Standard Error 0.08	0.18 Units on a scale Standard Error 0.08

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 11 subjects that were high myopes within the total completed population of 38.

Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	1.68 Units on a scale Standard Error 0.09	1.69 Units on a scale Standard Error 0.14

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 14 subjects that were hyperopes within the total completed population of 38.

Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)	0.96 Units on a scale Standard Error 0.10	1.17 Units on a scale Standard Error 0.08

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.

Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.12 Units on a scale Standard Error 0.09	1.42 Units on a scale Standard Error 0.08

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 11 subjects that were high myopes within the total completed population of 38.

Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=11 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	1.09 Units on a scale Standard Error 0.07	1.08 Units on a scale Standard Error 0.07

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 14 subjects that were hyperopes within the total completed population of 38.

Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=14 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)	1.12 Units on a scale Standard Error 0.06	1.21 Units on a scale Standard Error 0.09

PRIMARY outcome

Timeframe: after 6 hours of wear

Population: There were 13 subjects that were oblique astigmats within the total completed population of 38.

Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Outcome measures

Measure	Senofilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	Galyfilcon A n=13 Participants This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.01 Units on a scale Standard Error 0.05	1.10 Units on a scale Standard Error 0.04

Adverse Events

Senofilcon A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Galyfilcon A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Senofilcon A n=19 participants at risk senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.	Galyfilcon A n=20 participants at risk galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
Eye disorders asymptomatic infiltrative event	5.3% 1/19 • Number of events 1	0.00% 0/20
Eye disorders non-significant corneal infiltrate event	0.00% 0/19	10.0% 2/20 • Number of events 2

Additional Information

John Buch OD

Vistakon

Phone: 904-443-1707

Results disclosure agreements

• Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
• Publication restrictions are in place

Restriction type: OTHER