Trial Outcomes & Findings for Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses (NCT NCT00808834)
NCT ID: NCT00808834
Last Updated: 2012-06-29
Results Overview
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
196 participants
Primary outcome timeframe
30-60 seconds after initial insertion
Results posted on
2012-06-29
Participant Flow
Participant milestones
| Measure |
Senofilcon A / Lotrafilcon A
Senofilcon A, followed by Lotrafilcon A
|
Lotrafilcon A / Senofilcon A
Lotrafilcon A, followed by Senofilcon A
|
|---|---|---|
|
Period 1
STARTED
|
97
|
99
|
|
Period 1
COMPLETED
|
97
|
99
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
97
|
99
|
|
Period 2
COMPLETED
|
97
|
99
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Baseline characteristics by cohort
| Measure |
Overall
n=196 Participants
This reporting group includes all enrolled and exposed subjects.
|
|---|---|
|
Age Continuous
|
30.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
196 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-60 seconds after initial insertionPopulation: Per protocol
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Outcome measures
| Measure |
Senofilcon A
n=193 Participants
Commercially marketed, silicone hydrogel, spherical, soft contact lens
|
Lotrafilcon A
n=193 Participants
Investigational, silicone hydrogel, spherical, soft contact lens
|
|---|---|---|
|
Comfort After Insertion
|
8.7 Scale 1-10
Standard Deviation 1.5
|
7.7 Scale 1-10
Standard Deviation 2.4
|
Adverse Events
Senofilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lotrafilcon 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
Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
CIBA VISION
Phone: 1-800-241-7629
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER