Trial Outcomes & Findings for A Study to Compare a New Eye Drop Formulation With Refresh Contacts® (NCT NCT01844388)
NCT ID: NCT01844388
Last Updated: 2019-04-16
Results Overview
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
COMPLETED
PHASE3
365 participants
Baseline, Day 90
2019-04-16
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose Based Eye Drop Formula
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
REFRESH CONTACTS®
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
121
|
|
Overall Study
COMPLETED
|
236
|
114
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose Based Eye Drop Formula
n=244 Participants
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
REFRESH CONTACTS®
n=121 Participants
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40 years
|
170 participants
n=5 Participants
|
90 participants
n=7 Participants
|
260 participants
n=5 Participants
|
|
Age, Customized
≥40 years
|
74 participants
n=5 Participants
|
31 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-treat Population included all randomized participants.
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formula
n=244 Participants
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
REFRESH CONTACTS®
n=121 Participants
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
|---|---|---|
|
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Better
|
11.1 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
No Change
|
88.9 percentage of participants
|
88.4 percentage of participants
|
|
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Worse
|
0.0 percentage of participants
|
0.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90Population: Completed population included all enrolled participants who received study treatment and completed the study through Day 90.
The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formula
n=236 Participants
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
REFRESH CONTACTS®
n=114 Participants
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
|---|---|---|
|
Average Daily Contact Wearing Time
|
13.8 hours per day
Standard Deviation 2.59
|
13.9 hours per day
Standard Deviation 3.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90Population: Completed population included all enrolled participants who received study treatment and completed the study through Day 90.
The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formula
n=177 Contact Lenses Replaced
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
REFRESH CONTACTS®
n=86 Contact Lenses Replaced
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
|---|---|---|
|
Reason for Contact Lens Replacement
Scheduled Replacement
|
158 eyes
|
74 eyes
|
|
Reason for Contact Lens Replacement
Discomfort
|
11 eyes
|
5 eyes
|
|
Reason for Contact Lens Replacement
Lens Damage
|
9 eyes
|
7 eyes
|
|
Reason for Contact Lens Replacement
Unacceptable Vision
|
1 eyes
|
0 eyes
|
|
Reason for Contact Lens Replacement
Lens Lost
|
4 eyes
|
0 eyes
|
Adverse Events
Carboxymethylcellulose Based Eye Drop Formula
REFRESH CONTACTS®
Serious adverse events
| Measure |
Carboxymethylcellulose Based Eye Drop Formula
n=244 participants at risk
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
REFRESH CONTACTS®
n=121 participants at risk
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.55%
1/182
Treatment-emergent adverse events (adverse events which occur after study drug is first administered) are reported.
|
0.00%
0/90
Treatment-emergent adverse events (adverse events which occur after study drug is first administered) are reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER