Ametropia
Conditions
Brief summary
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
Interventions
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adapted contact lens wearer
Exclusion criteria
* Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | Change from Baseline at Day 90 | Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | Day 90 | Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboxymethylcellulose Sodium and Glycerin Carboxymethylcellulose sodium and Glycerin based rewetting drop | 166 |
| Carboxymethylcellulose Sodium Carboxymethylcellulose sodium based rewetting drop | 80 |
| Total | 246 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose Sodium and Glycerin | Carboxymethylcellulose Sodium | Total |
|---|---|---|---|
| Age, Continuous | 37.6 Years STANDARD_DEVIATION 11.94 | 36.8 Years STANDARD_DEVIATION 11.54 | 37.4 Years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 122 Participants | 53 Participants | 175 Participants |
| Sex: Female, Male Male | 44 Participants | 27 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 166 | 11 / 79 |
| serious Total, serious adverse events | 0 / 166 | 0 / 79 |
Outcome results
Primary
Best Corrected Visual Acuity
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
Time frame: Change from Baseline at Day 90
Population: Completed Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose Sodium and Glycerin | Best Corrected Visual Acuity | Better | 0.65 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Best Corrected Visual Acuity | No Change | 98.06 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Best Corrected Visual Acuity | Worse | 1.29 Percentage of Participants |
| Carboxymethylcellulose Sodium | Best Corrected Visual Acuity | Better | 1.33 Percentage of Participants |
| Carboxymethylcellulose Sodium | Best Corrected Visual Acuity | No Change | 98.67 Percentage of Participants |
| Carboxymethylcellulose Sodium | Best Corrected Visual Acuity | Worse | 0 Percentage of Participants |
Secondary
Corneal Staining
Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding
Time frame: Day 90
Population: Completed Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carboxymethylcellulose Sodium and Glycerin | Corneal Staining | 0 Participants |
| Carboxymethylcellulose Sodium | Corneal Staining | 1 Participants |
Post Hoc
Patient Acceptability
A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either Agree or Strongly Agree at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects)
Time frame: Day 90
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | RD gave good comfort during day (161/79) | 78.8 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | Vision was normal soon after using RD (161/79) | 85.7 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | At day's end,CL felt better after RD use (161/78) | 51.6 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | Vision with CL was better after RD use (161/79) | 31.0 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | RD on CL gave good initial comfort (161/79) | 49.0 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | Would likely purchase these RD (161/79) | 50.4 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | Could wear CL longer when using RD (161/79) | 46.6 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | Eyes felt better after CL removal (161/79) | 38.5 Percentage of Participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Acceptability | Liked using the RD (160/78) | 72.5 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | Eyes felt better after CL removal (161/79) | 43.1 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | Liked using the RD (160/78) | 82.1 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | RD gave good comfort during day (161/79) | 84.8 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | RD on CL gave good initial comfort (161/79) | 54.4 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | At day's end,CL felt better after RD use (161/78) | 62.8 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | Could wear CL longer when using RD (161/79) | 44.3 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | Vision was normal soon after using RD (161/79) | 81.0 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | Vision with CL was better after RD use (161/79) | 41.8 Percentage of Participants |
| Carboxymethylcellulose Sodium | Patient Acceptability | Would likely purchase these RD (161/79) | 68.4 Percentage of Participants |
Post Hoc
Patient Preference
Percentage of patients who used pre-study rewetting drops and answered Agree or Strongly Agree when asked if they preferred the study drops (SD) over their pre-study drops(PSD).
Time frame: Day 30
Population: Responders Completed Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose Sodium and Glycerin | Patient Preference | Prefer SD over PSD | 47.2 Percentage of participants |
| Carboxymethylcellulose Sodium and Glycerin | Patient Preference | SD more comfortable overall than PSD | 53.2 Percentage of participants |
| Carboxymethylcellulose Sodium | Patient Preference | Prefer SD over PSD | 41.5 Percentage of participants |
| Carboxymethylcellulose Sodium | Patient Preference | SD more comfortable overall than PSD | 34.1 Percentage of participants |