Trial Outcomes & Findings for Clinical Comparison of Two Silicone-Hydrogel Contact Lenses (NCT NCT00762385)

NCT ID: NCT00762385

Last Updated: 2018-06-19

Results Overview

\>0 = comfortable, \<0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 97 participants
• Primary outcome timeframe: 1-week, 2- weeks
• Results posted on: 2018-06-19

Participant Flow

Participant milestones

Measure	Galyfilcon A / Comfilcon A galyfilcon A contact lenses first period, comfilcon a contact lenses second period	Comfilcon A / Galyfilcon A comfilcon A contact lenses first period, galyfilcon A contact lenses second period
First Intervention STARTED	51	46
First Intervention COMPLETED	49	42
First Intervention NOT COMPLETED	2	4
Second Intervention STARTED	49	42
Second Intervention COMPLETED	46	39
Second Intervention NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Galyfilcon A / Comfilcon A galyfilcon A contact lenses first period, comfilcon a contact lenses second period	Comfilcon A / Galyfilcon A comfilcon A contact lenses first period, galyfilcon A contact lenses second period
First Intervention Lens Issue	1	1
First Intervention Lost to Follow-up	0	2
First Intervention Ineligible	1	0
First Intervention Protocol Violation	0	1
Second Intervention Protocol Violation	3	3

Baseline Characteristics

Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

Baseline characteristics by cohort

Measure	Completed Population n=85 Participants Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
Age, Continuous	28.2 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-week, 2- weeks

Population: Only participants who completed the study per protocol (n=78)

>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.

Outcome measures

Measure	Galyfilcon A n=78 Participants galyfilcon A administered in either the first intervention period or the second intervention period.	Comfilcon A n=78 Participants comfilcon A administered in either the first intervention period or second intervention period.
Lens Comfort	0.1452 combined score Standard Error 0.1097	0.1135 combined score Standard Error 0.1112

PRIMARY outcome

Timeframe: 1-week, 2-weeks

Population: Only participants who completed the study per protocol (n=78)

A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable

Outcome measures

Measure	Galyfilcon A n=78 Participants galyfilcon A administered in either the first intervention period or the second intervention period.	Comfilcon A n=78 Participants comfilcon A administered in either the first intervention period or second intervention period.
Comfort Symptoms	0.2440 score Standard Error 0.1262	-0.02862 score Standard Error 0.1275

SECONDARY outcome

Timeframe: 2 weeks

Population: Only the participants who completed the study per protocol (n=78)

Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.

Outcome measures

Measure	Galyfilcon A n=78 Participants galyfilcon A administered in either the first intervention period or the second intervention period.	Comfilcon A n=78 Participants comfilcon A administered in either the first intervention period or second intervention period.
Overall Corneal Staining	0.07582 combined score Standard Error 0.02192	0.07026 combined score Standard Error 0.02192

Adverse Events

Galyfilcon A / Comfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A / Galyfilcon A

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 FAAO

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