Dry Eye Syndromes
Conditions
Keywords
LASIK
Brief summary
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery
Interventions
DRUGCyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
DRUGArtificial Tears REFRESH ENDURA®
REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patient is scheduled for bilateral LASIK surgery * Patient is in good general health * Eye glasses prescription of -1 to -8
Exclusion criteria
* Significant Dry Eye * Presence of eye disease * Uncontrolled systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Clinical Success at Month 6 | Month 6 | Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Baseline, Month 6 | Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening). |
| Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Baseline, Month 6 | Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RESTASIS® Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) | 68 |
| REFRESH ENDURA® Artificial Tears (REFRESH ENDURA®) | 69 |
| Total | 137 |
Baseline characteristics
| Characteristic | RESTASIS® | REFRESH ENDURA® | Total |
|---|---|---|---|
| Age, Customized < 30 years | 19 participants | 21 participants | 40 participants |
| Age, Customized > 40 years | 24 participants | 24 participants | 48 participants |
| Age, Customized Between 30 and 40 years | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 43 Participants | 36 Participants | 79 Participants |
| Sex: Female, Male Male | 25 Participants | 33 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 68 | 8 / 69 |
| serious Total, serious adverse events | 1 / 68 | 1 / 69 |
Outcome results
Primary
Percentage of Patients With Clinical Success at Month 6
Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.
Time frame: Month 6
Population: Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of \< 25 mm in the 3 central regions of the eye on Day 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RESTASIS® | Percentage of Patients With Clinical Success at Month 6 | 64.3 Percentage of Patients |
| REFRESH ENDURA® | Percentage of Patients With Clinical Success at Month 6 | 58.1 Percentage of Patients |
Secondary
Change From Baseline in Goblet Cell Density of the Eyes at Month 6
Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).
Time frame: Baseline, Month 6
Population: Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RESTASIS® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Better Eye: Baseline | 60.9 Cells per square millimeter (cells/mm^2) |
| RESTASIS® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Better Eye: Change from Baseline at Month 6 | 30.9 Cells per square millimeter (cells/mm^2) |
| RESTASIS® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Worse Eye: Baseline | 68.4 Cells per square millimeter (cells/mm^2) |
| RESTASIS® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Worse Eye: Change from Baseline at Month 6 | 15.4 Cells per square millimeter (cells/mm^2) |
| REFRESH ENDURA® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Worse Eye: Change from Baseline at Month 6 | 9.9 Cells per square millimeter (cells/mm^2) |
| REFRESH ENDURA® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Better Eye: Baseline | 59.7 Cells per square millimeter (cells/mm^2) |
| REFRESH ENDURA® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Worse Eye: Baseline | 79.2 Cells per square millimeter (cells/mm^2) |
| REFRESH ENDURA® | Change From Baseline in Goblet Cell Density of the Eyes at Month 6 | Better Eye: Change from Baseline at Month 6 | -3.1 Cells per square millimeter (cells/mm^2) |
Secondary
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).
Time frame: Baseline, Month 6
Population: Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Better Eye: Baseline | 28095.7 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 5303.28 |
| RESTASIS® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Better Eye: Change from Baseline at Month 6 | 901.6 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 6117.69 |
| RESTASIS® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Worse Eye: Baseline | 26489.9 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 5161.53 |
| RESTASIS® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Worse Eye: Change from Baseline at Month 6 | 3011.7 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 7931.29 |
| REFRESH ENDURA® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Worse Eye: Change from Baseline at Month 6 | -218.4 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 5799.3 |
| REFRESH ENDURA® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Better Eye: Baseline | 26069.5 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 4648.48 |
| REFRESH ENDURA® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Worse Eye: Baseline | 27480.6 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 4854 |
| REFRESH ENDURA® | Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 | Better Eye: Change from Baseline at Month 6 | 1346.6 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 5550.24 |