Trial Outcomes & Findings for Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1 (NCT NCT01684033)
NCT ID: NCT01684033
Last Updated: 2014-04-17
Results Overview
Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
COMPLETED
NA
207 participants
Day 30
2014-04-17
Participant Flow
Participants were recruited from 5 study centers located in the US, 3 study centers located in the UK, and 2 study centers located in Germany.
Of the 207 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (198).
Participant milestones
| Measure |
PureMoist - Biotrue
Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
Biotrue - PureMoist
Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Period 1, First 30 Days
STARTED
|
99
|
99
|
|
Period 1, First 30 Days
COMPLETED
|
95
|
98
|
|
Period 1, First 30 Days
NOT COMPLETED
|
4
|
1
|
|
Period 2, Second 30 Days
STARTED
|
95
|
98
|
|
Period 2, Second 30 Days
COMPLETED
|
94
|
98
|
|
Period 2, Second 30 Days
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
PureMoist - Biotrue
Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
Biotrue - PureMoist
Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Period 1, First 30 Days
Adverse Event
|
1
|
1
|
|
Period 1, First 30 Days
Noncompliance
|
1
|
0
|
|
Period 1, First 30 Days
Withdrawal by Subject
|
1
|
0
|
|
Period 1, First 30 Days
Lost to Follow-up
|
1
|
0
|
|
Period 2, Second 30 Days
Adverse Event
|
1
|
0
|
Baseline Characteristics
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1
Baseline characteristics by cohort
| Measure |
PureMoist / Biotrue
n=198 Participants
Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
|
|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 11.48 • n=99 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: This analysis population group includes all participants who were exposed to both treatment regimens.
Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Outcome measures
| Measure |
PureMoist
n=192 Participants
Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
|
Biotrue
n=192 Participants
Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Corneal Staining
|
1.9 Units on a scale
Standard Deviation 2.30
|
2.8 Units on a scale
Standard Deviation 2.62
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 30Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Outcome measures
| Measure |
PureMoist
n=192 Participants
Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
|
Biotrue
n=192 Participants
Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
|
|---|---|---|
|
Change From Baseline in Corneal Staining at Day 30
|
0.7 units on a scale
Standard Deviation 2.59
|
1.6 units on a scale
Standard Deviation 2.91
|
Adverse Events
PureMoist
Biotrue
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER