Contact Lens Lubrication
Conditions
Brief summary
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
Interventions
DRUGcarboxymethylcellulose 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.
DRUGcarboxymethylcellulose sodium based eye drop solution
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.
Exclusion criteria
* Wearing monovision lenses * Have had refractive surgery within the previous 12 months * Have infection of the eye, eyelids or eye structures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | Baseline, Day 90 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Contact Wearing Time | Day 90 | The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days. |
| Reason for Contact Lens Replacement | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 244 |
| 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. | 121 |
| Total | 365 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose Based Eye Drop Formula | REFRESH CONTACTS® | Total |
|---|---|---|---|
| Age, Customized <40 years | 170 participants | 90 participants | 260 participants |
| Age, Customized ≥40 years | 74 participants | 31 participants | 105 participants |
| Sex: Female, Male Female | 182 Participants | 90 Participants | 272 Participants |
| Sex: Female, Male Male | 62 Participants | 31 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 244 | 0 / 121 |
| serious Total, serious adverse events | 1 / 244 | 0 / 121 |
Outcome results
Primary
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
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.
Time frame: Baseline, Day 90
Population: Intent-to-treat Population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formula | Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | Better | 11.1 percentage of participants |
| Carboxymethylcellulose Based Eye Drop Formula | Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | No Change | 88.9 percentage of participants |
| Carboxymethylcellulose Based Eye Drop Formula | Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | Worse | 0.0 percentage of participants |
| REFRESH CONTACTS® | Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | Better | 10.7 percentage of participants |
| REFRESH CONTACTS® | Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | No Change | 88.4 percentage of participants |
| REFRESH CONTACTS® | Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | Worse | 0.8 percentage of participants |
Other Pre-specified
Average Daily Contact Wearing Time
The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.
Time frame: Day 90
Population: Completed population included all enrolled participants who received study treatment and completed the study through Day 90.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formula | Average Daily Contact Wearing Time | 13.8 hours per day | Standard Deviation 2.59 |
| REFRESH CONTACTS® | Average Daily Contact Wearing Time | 13.9 hours per day | Standard Deviation 3.01 |
Other Pre-specified
Reason for Contact Lens Replacement
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.
Time frame: Day 90
Population: Completed population included all enrolled participants who received study treatment and completed the study through Day 90.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formula | Reason for Contact Lens Replacement | Discomfort | 11 eyes |
| Carboxymethylcellulose Based Eye Drop Formula | Reason for Contact Lens Replacement | Unacceptable Vision | 1 eyes |
| Carboxymethylcellulose Based Eye Drop Formula | Reason for Contact Lens Replacement | Lens Damage | 9 eyes |
| Carboxymethylcellulose Based Eye Drop Formula | Reason for Contact Lens Replacement | Lens Lost | 4 eyes |
| Carboxymethylcellulose Based Eye Drop Formula | Reason for Contact Lens Replacement | Scheduled Replacement | 158 eyes |
| REFRESH CONTACTS® | Reason for Contact Lens Replacement | Lens Lost | 0 eyes |
| REFRESH CONTACTS® | Reason for Contact Lens Replacement | Scheduled Replacement | 74 eyes |
| REFRESH CONTACTS® | Reason for Contact Lens Replacement | Discomfort | 5 eyes |
| REFRESH CONTACTS® | Reason for Contact Lens Replacement | Lens Damage | 7 eyes |
| REFRESH CONTACTS® | Reason for Contact Lens Replacement | Unacceptable Vision | 0 eyes |