Pterygium
Conditions
Brief summary
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
Interventions
DRUGVehicle
One drop in the study eye (or eyes) administered four times daily (QID)
One drop in the study eye (or eyes) administered four times daily (QID)
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
No
Inclusion criteria
* Have a pterygium in at least one eye that has not been previously removed with surgery
Exclusion criteria
* Uncontrolled systemic disease * Active eye disease * Current or anticipated use of topical eye medications other than artificial tears. * Anticipated wearing of contact lenses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pterygium Hyperemia Responders at Week 16 | Week 16 | Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia. |
| Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Baseline, Week 16 | Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Baseline, Week 16 | Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. 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). A negative number change from baseline represents an improvement. |
Countries
Australia, Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% One drop in the study eye (or eyes) administered four times daily (QID) | 57 |
| Vehicle One drop in the study eye (or eyes) administered four times daily (QID) | 58 |
| Total | 115 |
Baseline characteristics
| Characteristic | Cyclosporine Ophthalmic Emulsion 0.05% | Vehicle | Total |
|---|---|---|---|
| Age, Customized <45 years | 13 Participants | 15 Participants | 28 Participants |
| Age, Customized >65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Customized Between 45 and 65 years | 36 Participants | 36 Participants | 72 Participants |
| Sex: Female, Male Female | 16 Participants | 23 Participants | 39 Participants |
| Sex: Female, Male Male | 41 Participants | 35 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 56 | 16 / 58 |
| serious Total, serious adverse events | 1 / 56 | 1 / 58 |
Outcome results
Primary
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.
Time frame: Baseline, Week 16
Population: Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% | Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Baseline | 3.1 Scores on a Scale | Standard Deviation 0.35 |
| Cyclosporine Ophthalmic Emulsion 0.05% | Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Change from Baseline at Week 16 | -0.7 Scores on a Scale | Standard Deviation 0.76 |
| Vehicle | Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Baseline | 3.2 Scores on a Scale | Standard Deviation 0.37 |
| Vehicle | Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Change from Baseline at Week 16 | -0.8 Scores on a Scale | Standard Deviation 0.75 |
Primary
Number of Pterygium Hyperemia Responders at Week 16
Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
Time frame: Week 16
Population: Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% | Number of Pterygium Hyperemia Responders at Week 16 | 6 Participants |
| Vehicle | Number of Pterygium Hyperemia Responders at Week 16 | 8 Participants |
Secondary
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16
Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. 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). A negative number change from baseline represents an improvement.
Time frame: Baseline, Week 16
Population: Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine Ophthalmic Emulsion 0.05% | Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Change from Baseline at Week 16 | -3.1 Scores on a Scale | Standard Deviation 14.95 |
| Cyclosporine Ophthalmic Emulsion 0.05% | Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Baseline | 20.2 Scores on a Scale | Standard Deviation 16.97 |
| Vehicle | Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Baseline | 29.3 Scores on a Scale | Standard Deviation 26.89 |
| Vehicle | Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Change from Baseline at Week 16 | -10.5 Scores on a Scale | Standard Deviation 16.02 |