Trial Outcomes & Findings for Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses (NCT NCT00813982)
NCT ID: NCT00813982
Last Updated: 2023-05-26
Results Overview
Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
COMPLETED
NA
60 participants
1 week
2023-05-26
Participant Flow
One participant was enrolled but not dispensed due to failing inclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participant milestones
| Measure |
Experimental Contact Lens / Commercial Contact Lens
Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
Baseline characteristics by cohort
| Measure |
Experimental Contact Lens / Commercial Contact Lens
n=59 Participants
Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
|
|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.
Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Outcome measures
| Measure |
Lotrafilcon A Commercial Contact Lens
n=56 Participants
Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
|
Lotrafilcon A Experimental Contact Lens
n=56 Participants
Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
|
|---|---|---|
|
Overall Vision
|
8.7 Units on a Scale
Standard Deviation 1.5
|
8.7 Units on a Scale
Standard Deviation 1.7
|
Adverse Events
Lotrafilcon A Commercial Contact Lens
Lotrafilcon A Experimental Contact Lens
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
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 pre-clinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER