Trial Outcomes & Findings for Performance of Two Silicone Hydrogel Toric Contact Lenses (NCT NCT00638846)

NCT ID: NCT00638846

Last Updated: 2015-05-21

Results Overview

Proportion of eyes with lens orientation within 5 degrees of optimal

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 276 participants
• Primary outcome timeframe: 1 minute after insertion
• Results posted on: 2015-05-21

Participant Flow

Participant milestones

Measure	Senofilcon A Toric senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric balafilcon A toric contact lens. Analysis includes participants that completed the study.
Overall Study STARTED	137	139
Overall Study COMPLETED	133	133
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	Senofilcon A Toric senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric balafilcon A toric contact lens. Analysis includes participants that completed the study.
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	3	2
Overall Study lens issue	1	3

Baseline Characteristics

Performance of Two Silicone Hydrogel Toric Contact Lenses

Baseline characteristics by cohort

Measure	Senofilcon A Toric n=137 Participants senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=139 Participants balafilcon A toric contact lens. Analysis includes participants that completed the study.	Total n=276 Participants Total of all reporting groups
Age, Continuous	29.81 years STANDARD_DEVIATION 6.99 • n=93 Participants	30.13 years STANDARD_DEVIATION 7.69 • n=4 Participants	29.97 years STANDARD_DEVIATION 7.33 • n=27 Participants
Gender Female	91 participants n=93 Participants	92 participants n=4 Participants	183 participants n=27 Participants
Gender Male	46 participants n=93 Participants	45 participants n=4 Participants	91 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 minute after insertion

Population: Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses.

Proportion of eyes with lens orientation within 5 degrees of optimal

Outcome measures

Measure	Senofilcon A Toric n=266 eyes senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=266 eyes balafilcon A toric contact lens. Analysis includes participants that completed the study.
Lens Orientation	0.77 proportion of eyes	0.66 proportion of eyes

PRIMARY outcome

Timeframe: 10-15 minutes after insertion

Population: Analysis was performed on participants who completed the study per protocol.

Lens stability is measured as the amount of rotation induced from blink after the lens has settled.

Outcome measures

Measure	Senofilcon A Toric n=266 eyes senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=266 eyes balafilcon A toric contact lens. Analysis includes participants that completed the study.
Lens Stability	0.89 proportion of eyes	0.88 proportion of eyes

PRIMARY outcome

Timeframe: 2 weeks of lens wear

Population: Analysis was performed on participants who completed the study per protocol.

Subjective comfort was derived from 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. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.

Outcome measures

Measure	Senofilcon A Toric n=133 Participants senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=133 Participants balafilcon A toric contact lens. Analysis includes participants that completed the study.
Subjective Comfort	0.1942 units on a scale Standard Error 0.09637	-0.1738 units on a scale Standard Error 0.09716

SECONDARY outcome

Timeframe: after lens insertion

Population: Analysis was performed on participants who completed the study per protocol.

Time required for the optometrist to fit the lens.

Outcome measures

Measure	Senofilcon A Toric n=133 Participants senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=133 Participants balafilcon A toric contact lens. Analysis includes participants that completed the study.
Time to Fit Lens	6.2789 minutes Standard Error 0.2045	7.4095 minutes Standard Error 0.1994

SECONDARY outcome

Timeframe: measured at 1 and 2 weeks

Population: Analysis was performed on participants who completed the study per protocol.

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. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.

Outcome measures

Measure	Senofilcon A Toric n=133 Participants senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=133 Participants balafilcon A toric contact lens. Analysis includes participants that completed the study.
Subjective Lens Vision	0.1942 units on a scale Standard Error 0.09637	-0.1738 units on a scale Standard Error 0.09716

SECONDARY outcome

Timeframe: After 2 weeks use

Population: Analysis was performed on participants who completed the study per protocol.

National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.

Outcome measures

Measure	Senofilcon A Toric n=133 Participants senofilcon A toric contact lens. Analysis includes participants that completed the study.	Balafilcon A Toric n=133 Participants balafilcon A toric contact lens. Analysis includes participants that completed the study.
Overall Corneal Staining	0.0919 units on a scale Standard Error 0.0178	0.1607 units on a scale Standard Error 0.0178

Adverse Events

Senofilcon A Toric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Balafilcon 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