Trial Outcomes & Findings for Comparison of Two Toric Contact Lenses on Current Toric Wearers (NCT NCT00639379)

NCT ID: NCT00639379

Last Updated: 2015-05-21

Results Overview

Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 89 participants
• Primary outcome timeframe: 1 minute after insertion
• Results posted on: 2015-05-21

Participant Flow

Participant milestones

Measure	Senofilcon A Toric / Alphafilcon A Toric senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.	Alphafilcon A Toric / Senofilcon A Toric alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
Period 1 - 2 Weeks STARTED	44	45
Period 1 - 2 Weeks COMPLETED	39	45
Period 1 - 2 Weeks NOT COMPLETED	5	0
Period 2 - 2 Weeks STARTED	39	45
Period 2 - 2 Weeks COMPLETED	39	45
Period 2 - 2 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Senofilcon A Toric / Alphafilcon A Toric senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.	Alphafilcon A Toric / Senofilcon A Toric alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
Period 1 - 2 Weeks Lost to Follow-up	2	0
Period 1 - 2 Weeks lens issue	3	0

Baseline Characteristics

Comparison of Two Toric Contact Lenses on Current Toric Wearers

Baseline characteristics by cohort

Measure	Total Completed Participants n=84 Participants
Age, Continuous	31.6 years STANDARD_DEVIATION 8.05 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 minute after insertion

Population: Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.

Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

Outcome measures

Measure	Senofilcon A Toric n=84 Participants	Alphafilcon A Toric n=84 Participants
Lens Orientation Within 5 Degrees	128 Eyes	128 Eyes

PRIMARY outcome

Timeframe: 10-15 minutes after insertion

Population: Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.

Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.

Outcome measures

Measure	Senofilcon A Toric n=84 Participants	Alphafilcon A Toric n=84 Participants
Lens Stability	144 Eyes	138 Eyes

PRIMARY outcome

Timeframe: 1 and 2 weeks

Population: Subjects that completed the study were analyzed.

A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.

Outcome measures

Measure	Senofilcon A Toric n=84 Participants	Alphafilcon A Toric n=84 Participants
Subjective Lens Comfort	0.08125 Units on a scale Standard Error 0.08771	-0.1055 Units on a scale Standard Error 0.08771

PRIMARY outcome

Timeframe: 1 and 2 weeks

Population: Subjects that completed the study were analyzed.

A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.

Outcome measures

Measure	Senofilcon A Toric n=84 Participants	Alphafilcon A Toric n=84 Participants
Subjective Vision	-0.0420 Units on a scale Standard Error 0.08885	-0.0302 Units on a scale Standard Error 0.08885

PRIMARY outcome

Timeframe: after 2 weeks use

Population: Subjects that completed the study were analyzed.

Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Outcome measures

Measure	Senofilcon A Toric n=84 Participants	Alphafilcon A Toric n=84 Participants
Overall Corneal Staining	0.04921 Units on a scale Standard Error 0.01174	0.06188 Units on a scale Standard Error 0.01176

Adverse Events

Senofilcon A Toric / Alphafilcon A Toric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alphafilcon A Toric / Senofilcon A Toric

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

Kurt Moody, OD

Vistakon

Phone: 904-443-3088

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