Bilateral LASIK Surgery
Conditions
Brief summary
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
Interventions
DRUGcarboxymethylcellulose sodium based new eye drop formulation
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
-Patients scheduled for LASIK surgery in both eyes.
Exclusion criteria
* Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision * Use of topical eye medication other than prescribed for use in pre- or post-operative care * Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening * Eye infection, inflammation, or allergy * Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale | Day 90 | The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining in the Worse Eye | Baseline, Day 90 | The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and 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) and a positive change from baseline represents an increase in corneal staining (worsening). |
| Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye | Baseline, Day 90 | TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening). |
| Change From Baseline in the Schirmer Test in the Worse Eye | Baseline, Day 90 | The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening). |
| Change From Baseline in Uncorrected Visual Acuity in the Worse Eye | Baseline, Day 90 | Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening. |
Countries
Australia, Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Eye Drop Formulation 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. | 75 |
| REFRESH PLUS® 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. | 73 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Personal Reasons | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | New Eye Drop Formulation | REFRESH PLUS® | Total |
|---|---|---|---|
| Age, Customized < 40 years | 58 Participants | 51 Participants | 109 Participants |
| Age, Customized ≥ 40 years | 17 Participants | 22 Participants | 39 Participants |
| Sex: Female, Male Female | 36 Participants | 39 Participants | 75 Participants |
| Sex: Female, Male Male | 39 Participants | 34 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 75 | 18 / 73 |
| serious Total, serious adverse events | 0 / 75 | 1 / 73 |
Outcome results
Primary
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).
Time frame: Day 90
Population: Per Protocol: all randomized patients who had no significant protocol violations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Eye Drop Formulation | Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale | 6.99 Scores on a Scale | Standard Deviation 8.511 |
| REFRESH PLUS® | Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale | 6.63 Scores on a Scale | Standard Deviation 7.071 |
Secondary
Change From Baseline in Corneal Staining in the Worse Eye
The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and 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) and a positive change from baseline represents an increase in corneal staining (worsening).
Time frame: Baseline, Day 90
Population: Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation | Change From Baseline in Corneal Staining in the Worse Eye | Baseline | 0.9 Scores on a Scale | Standard Deviation 1.28 |
| New Eye Drop Formulation | Change From Baseline in Corneal Staining in the Worse Eye | Change from Baseline at Day 90 (N=68, 57) | 0.2 Scores on a Scale | Standard Deviation 1.96 |
| REFRESH PLUS® | Change From Baseline in Corneal Staining in the Worse Eye | Baseline | 1.2 Scores on a Scale | Standard Deviation 1.31 |
| REFRESH PLUS® | Change From Baseline in Corneal Staining in the Worse Eye | Change from Baseline at Day 90 (N=68, 57) | -0.3 Scores on a Scale | Standard Deviation 1.61 |
Secondary
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye
TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Time frame: Baseline, Day 90
Population: Intent-to-Treat: all randomized patients who had data at the noted time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation | Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye | Baseline | 11.88 Seconds | Standard Deviation 11.656 |
| New Eye Drop Formulation | Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye | Change from Baseline at Day 90 (N=75, 71) | 1.21 Seconds | Standard Deviation 9.299 |
| REFRESH PLUS® | Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye | Baseline | 9.27 Seconds | Standard Deviation 5.121 |
| REFRESH PLUS® | Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye | Change from Baseline at Day 90 (N=75, 71) | 1.08 Seconds | Standard Deviation 5.304 |
Secondary
Change From Baseline in the Schirmer Test in the Worse Eye
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Time frame: Baseline, Day 90
Population: Intent-to-Treat: all randomized patients who had data at the noted time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation | Change From Baseline in the Schirmer Test in the Worse Eye | Baseline | 13.1 Millimeters in 5 minutes (mm/5 min) | Standard Deviation 9.1 |
| New Eye Drop Formulation | Change From Baseline in the Schirmer Test in the Worse Eye | Change from Baseline at Day 90 (N=75, 71) | 1.4 Millimeters in 5 minutes (mm/5 min) | Standard Deviation 8.55 |
| REFRESH PLUS® | Change From Baseline in the Schirmer Test in the Worse Eye | Baseline | 13.0 Millimeters in 5 minutes (mm/5 min) | Standard Deviation 8.74 |
| REFRESH PLUS® | Change From Baseline in the Schirmer Test in the Worse Eye | Change from Baseline at Day 90 (N=75, 71) | 1.3 Millimeters in 5 minutes (mm/5 min) | Standard Deviation 9.89 |
Secondary
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye
Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.
Time frame: Baseline, Day 90
Population: Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Eye Drop Formulation | Change From Baseline in Uncorrected Visual Acuity in the Worse Eye | Baseline | 51.1 Letters Read Correctly | Standard Deviation 10 |
| New Eye Drop Formulation | Change From Baseline in Uncorrected Visual Acuity in the Worse Eye | Change from Baseline at Day 90 (N=68, 57) | 5.8 Letters Read Correctly | Standard Deviation 5.24 |
| REFRESH PLUS® | Change From Baseline in Uncorrected Visual Acuity in the Worse Eye | Baseline | 53.1 Letters Read Correctly | Standard Deviation 9.49 |
| REFRESH PLUS® | Change From Baseline in Uncorrected Visual Acuity in the Worse Eye | Change from Baseline at Day 90 (N=68, 57) | 4.7 Letters Read Correctly | Standard Deviation 6.02 |