Keratoconjunctivitis Sicca
Conditions
Brief summary
This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
Interventions
DRUGcyclosporine ophthalmic emulsion 0.05%, artificial tears
one drop, twice a day in each eye
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of dry eye disease * Currently using artificial tears daily * Male or female of legal age of consent * Normal lid position and closure
Exclusion criteria
* Patients currently using cyclosporine ophthalmic emulsion 0.05% * Participation in other investigational drug or device study * Any current or previous topical ophthalmic or oral cyclosporine use within the last three years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Total Score at Baseline | Baseline | The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Schirmer's Test With and Without Anesthesia at Baseline | Baseline | Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production. |
Countries
United States
Participant flow
Pre-assignment details
Treatment for this study was per normal clinical practice and not assigned.
Participants by arm
| Arm | Count |
|---|---|
| Restasis® Alone cyclosporine ophthalmic emulsion 0.05% | 180 |
| Artificial Tears Alone | 74 |
| Combination Treatments | 508 |
| Missing Treatment Information | 19 |
| Total | 781 |
Baseline characteristics
| Characteristic | Restasis® Alone | Artificial Tears Alone | Combination Treatments | Missing Treatment Information | Total |
|---|---|---|---|---|---|
| Age Continuous | 55.0 years | 64.5 years | 60.0 years | 61.0 years | 60.0 years |
| Sex: Female, Male Female | 125 Participants | 62 Participants | 425 Participants | 15 Participants | 627 Participants |
| Sex: Female, Male Male | 55 Participants | 12 Participants | 83 Participants | 4 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Ocular Surface Disease Index (OSDI) Total Score at Baseline
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).
Time frame: Baseline
Population: Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Ocular Surface Disease Index (OSDI) Total Score at Baseline | 40.3 Scores on a Scale | Standard Deviation 22 |
Other Pre-specified
Schirmer's Test With and Without Anesthesia at Baseline
Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.
Time frame: Baseline
Population: Intent-to-treat, which included all patients who started the study (completed baseline visit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | Schirmer's Test With and Without Anesthesia at Baseline | Schirmer's Test without Anesthesia | 9.6 millimeters (mm) | Standard Deviation 7.9 |
| All Patients | Schirmer's Test With and Without Anesthesia at Baseline | Schirmer's Test with Anesthesia | 8.1 millimeters (mm) | Standard Deviation 6.3 |