Dry Eye Syndrome
Conditions
Brief summary
This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery
Interventions
As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
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
* Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters
Exclusion criteria
* Dry eye signs and symptoms * Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively * Pregnancy or planning pregnancy * Uncontrolled systemic disease * Use of systemic medications affecting dry eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 | Day 90 | Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Day 90 | A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree. |
| Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Day 90 | A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree. |
| Best Corrected Visual Acuity (BCVA) Status at Day 90 | Day 90 | BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly. |
| Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Baseline, Day 90 | Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement. |
| Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Baseline, Day 90 | Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement. |
| Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Baseline, Day 90 | Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye. |
| Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Baseline, Day 90 | Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement). |
| Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Baseline, Day 90 | Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement). |
| Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Baseline, Day 90 | Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). |
| Change From Baseline in Study Product Usage at Day 90 | Baseline, Day 90 | Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement). |
| Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Baseline, Day 90 | Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14, Day 60 | Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear Carboxymethylcellulose and Glycerin based artificial tear | 114 |
| Carboxymethylcellulose Based Artificial Tear Carboxymethylcellulose based artificial tear | 114 |
| Total | 228 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose and Glycerin Based Artificial Tear | Carboxymethylcellulose Based Artificial Tear | Total |
|---|---|---|---|
| Age, Customized <40 Years | 88 participants | 92 participants | 180 participants |
| Age, Customized >= 40 Years | 26 participants | 22 participants | 48 participants |
| Sex: Female, Male Female | 62 Participants | 51 Participants | 113 Participants |
| Sex: Female, Male Male | 52 Participants | 63 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 114 | 82 / 114 |
| serious Total, serious adverse events | 0 / 114 | 0 / 114 |
Outcome results
Primary
Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).
Time frame: Day 90
Population: Intent to Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 | 8.32 Scores on a Scale | Standard Deviation 11.125 |
| Carboxymethylcellulose Based Artificial Tear | Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 | 6.43 Scores on a Scale | Standard Deviation 8.036 |
Secondary
Best Corrected Visual Acuity (BCVA) Status at Day 90
BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly.
Time frame: Day 90
Population: Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Best Corrected Visual Acuity (BCVA) Status at Day 90 | Better | 8 Number of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Best Corrected Visual Acuity (BCVA) Status at Day 90 | No Change | 104 Number of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Best Corrected Visual Acuity (BCVA) Status at Day 90 | Worse | 1 Number of Patients |
| Carboxymethylcellulose Based Artificial Tear | Best Corrected Visual Acuity (BCVA) Status at Day 90 | Better | 7 Number of Patients |
| Carboxymethylcellulose Based Artificial Tear | Best Corrected Visual Acuity (BCVA) Status at Day 90 | No Change | 107 Number of Patients |
| Carboxymethylcellulose Based Artificial Tear | Best Corrected Visual Acuity (BCVA) Status at Day 90 | Worse | 0 Number of Patients |
Secondary
Change From Baseline in Study Product Usage at Day 90
Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).
Time frame: Baseline, Day 90
Population: Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline in Study Product Usage at Day 90 | Baseline (108/108) | 7.9 Number of study product uses per day | Standard Deviation 3.16 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline in Study Product Usage at Day 90 | Change from Baseline at Day 90 (108/105) | -4.9 Number of study product uses per day | Standard Deviation 3.38 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline in Study Product Usage at Day 90 | Baseline (108/108) | 7.9 Number of study product uses per day | Standard Deviation 4.89 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline in Study Product Usage at Day 90 | Change from Baseline at Day 90 (108/105) | -4.5 Number of study product uses per day | Standard Deviation 5.97 |
Secondary
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Time frame: Baseline, Day 90
Population: Intent-to-Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Baseline | 1.0 Scores on a Scale | Standard Deviation 1.98 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Change from Baseline at Day 90 | 0.0 Scores on a Scale | Standard Deviation 1.65 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Baseline | 0.8 Scores on a Scale | Standard Deviation 1.32 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Change from Baseline at Day 90 | -0.3 Scores on a Scale | Standard Deviation 1.24 |
Secondary
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).
Time frame: Baseline, Day 90
Population: Intent to Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Baseline | 0.5 Scores on a Scale | Standard Deviation 1.13 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Change from Baseline at Day 90 | 0.0 Scores on a Scale | Standard Deviation 1.12 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Baseline | 0.5 Scores on a Scale | Standard Deviation 1.12 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Change from Baseline at Day 90 | 0.0 Scores on a Scale | Standard Deviation 1.47 |
Secondary
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.
Time frame: Baseline, Day 90
Population: Intent-to-Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Baseline | 31.95 Units on a scale | Standard Deviation 11.941 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Change from Baseline at Day 90 | -2.12 Units on a scale | Standard Deviation 6.321 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Baseline | 32.32 Units on a scale | Standard Deviation 15.347 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Change from Baseline at Day 90 | -2.24 Units on a scale | Standard Deviation 6.267 |
Secondary
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.
Time frame: Baseline, Day 90
Population: Intent-to-Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Baseline | 1.32 Units on a scale | Standard Deviation 0.855 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Change from Baseline at Day 90 | -0.49 Units on a scale | Standard Deviation 0.899 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Baseline | 1.25 Units on a scale | Standard Deviation 0.456 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Change from Baseline at Day 90 | -0.26 Units on a scale | Standard Deviation 0.396 |
Secondary
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.
Time frame: Baseline, Day 90
Population: Intent-to-Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Baseline | 16.3 Millimeters of Tears | Standard Deviation 8.4 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Change from Baseline at Day 90 | -0.3 Millimeters of Tears | Standard Deviation 8.75 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Baseline | 13.5 Millimeters of Tears | Standard Deviation 6.3 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Change from Baseline at Day 90 | 1.7 Millimeters of Tears | Standard Deviation 9.59 |
Secondary
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Time frame: Baseline, Day 90
Population: Intent-to-Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Baseline | 13.66 Number of seconds | Standard Deviation 6.133 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Change from Baseline at Day 90 | -0.92 Number of seconds | Standard Deviation 6.013 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Baseline | 13.25 Number of seconds | Standard Deviation 5.25 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Change from Baseline at Day 90 | -0.87 Number of seconds | Standard Deviation 12.924 |
Secondary
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.
Time frame: Baseline, Day 90
Population: Intent-to-Treat population defined as all patients who started the study and were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Baseline | 0.521 Microns | Standard Deviation 0.1842 |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Change from Baseline at Day 90 | -0.058 Microns | Standard Deviation 0.1509 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Baseline | 0.520 Microns | Standard Deviation 0.1845 |
| Carboxymethylcellulose Based Artificial Tear | Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Change from Baseline at Day 90 | -0.047 Microns | Standard Deviation 0.1452 |
Secondary
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree.
Time frame: Day 90
Population: Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Liked using these AT (112/110) | 88.4 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT helped eyes feel comfortable (112/110) | 94.6 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were soothing to eyes (111/110) | 95.5 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT protected eyes from dryness (112/109) | 88.4 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT protected eyes from low humidity (112/110) | 78.6 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Vision was normal few min.after AT use(112/110) | 93.8 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Few min. after use, AT gave clear vision(111/110) | 94.6 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT helped eyes heal from surgery (112/110) | 83.9 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT helped eyes feel same as pre-LASIK (111/110) | 85.6 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | It's good to use AT after surgery(111/109) | 97.3 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT helped eyes heal from surgery (112/110) | 86.4 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Liked using these AT (112/110) | 93.6 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Vision was normal few min.after AT use(112/110) | 92.7 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT helped eyes feel comfortable (112/110) | 94.5 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | It's good to use AT after surgery(111/109) | 96.3 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were soothing to eyes (111/110) | 95.4 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Few min. after use, AT gave clear vision(111/110) | 94.5 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT protected eyes from dryness (112/109) | 89.9 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT helped eyes feel same as pre-LASIK (111/110) | 89.1 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT protected eyes from low humidity (112/110) | 82.7 Percentage of Patients |
Secondary
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree.
Time frame: Day 90
Population: Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were convenient to use (112/109) | 96.4 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | I no longer feel I need to use AT (111/108) | 43.2 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were helpful to achieve comfort (112/109) | 92.0 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Thickness of AT is just right (112/109) | 79.5 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were important to a good outcome (111/109) | 82.0 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT did not interfere with vision (112/108) | 64.3 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were helpful to achieve good vision (112/109) | 71.4 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT did not cause my eyes to get crusty (112/108) | 66.1 Percentage of Patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were easy to use (112/109) | 99.1 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT did not cause my eyes to get crusty (112/108) | 80.6 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were easy to use (112/109) | 99.1 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were convenient to use (112/109) | 91.7 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were important to a good outcome (111/109) | 80.7 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were helpful to achieve comfort (112/109) | 93.6 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT were helpful to achieve good vision (112/109) | 76.1 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | I no longer feel I need to use AT (111/108) | 38.0 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | Thickness of AT is just right (112/109) | 87.2 Percentage of Patients |
| Carboxymethylcellulose Based Artificial Tear | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | AT did not interfere with vision (112/108) | 82.4 Percentage of Patients |
Other Pre-specified
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.
Time frame: Day 14, Day 60
Population: Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: at least every 2 hrs (113/110) | 20 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: at least every 2 hrs (109/107) | 4 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: 3-5 times a day (113/110) | 58 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: 6-8 times a day (109/107) | 12 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: 6-8 times a day (113/110) | 30 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: 3-5 times a day (109/107) | 62 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: 1-2 times a day (113/110) | 5 Number of patients |
| Carboxymethylcellulose and Glycerin Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: 1-2 times a day (109/107) | 31 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: 1-2 times a day (113/110) | 4 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: at least every 2 hrs (113/110) | 22 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: 6-8 times a day (113/110) | 30 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 14: 3-5 times a day (113/110) | 54 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: 1-2 times a day (109/107) | 30 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: at least every 2 hrs (109/107) | 3 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: 6-8 times a day (109/107) | 14 Number of patients |
| Carboxymethylcellulose Based Artificial Tear | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Day 60: 3-5 times a day (109/107) | 60 Number of patients |