Dry Eye Syndrome
Conditions
Keywords
Dry Eye Syndrome, Recent Diagnosis of Dry Eye Syndrome
Brief summary
The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.
Interventions
DRUGOral Omega-3-acid ethyl esters
1 gram capsule by mouth four times daily for 45 days
DRUGPlacebo corn oil capsule
1 gram by mouth 4 times daily for 45 days
Sponsors
The American Society of Cataract and Refractive Surgery Foundation
GlaxoSmithKline
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking) * Schirmer Test \< 8 mm/5 minutes * Fluorescein tear break-up time \< 8 seconds * No current use of dry eye treatment (except artificial lubrication) * Signature on consent form
Exclusion criteria
* Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye * Eyelid or eyelash abnormalities * Alteration of the nasolacrimal apparatus * Treatment with drugs affecting tearing * Concomitant ocular therapies * Topical ophthalmic steroids taken during the 4 weeks before the study * Pregnant/breast-feeding women * History of liver disease * History of fish and/or shellfish allergy or hypersensitivity * History of corn allergy or hypersensitivity * Treatment with systemic anticoagulation therapy * Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of the Ocular Surface Disease Index Score at Day 45 | Baseline and Day 45 | The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Schirmer-1 Test Value at Day 45 | Baseline and Day 45 | Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value). |
| Change From Baseline of Lissamine Green Staining Score at Day 45 | Baseline and Day 45 | Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score) |
| Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 | Baseline and Day 45 | Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omega-3-acid Ethyl Esters Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days | 13 |
| Corn Oil Capsule Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Omega-3-acid Ethyl Esters | Corn Oil Capsule | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 60 years | 58 years |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 2 / 13 | 1 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Change From Baseline of the Ocular Surface Disease Index Score at Day 45
The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)
Time frame: Baseline and Day 45
Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega-3-acid Ethyl Esters | Change From Baseline of the Ocular Surface Disease Index Score at Day 45 | -28.4 units on a scale |
| Corn Oil Capsule | Change From Baseline of the Ocular Surface Disease Index Score at Day 45 | -5.8 units on a scale |
p-value: 0.61Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value).
Time frame: Baseline and Day 45
Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega-3-acid Ethyl Esters | Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 | 1.7 time in seconds |
| Corn Oil Capsule | Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 | 0.3 time in seconds |
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline of Lissamine Green Staining Score at Day 45
Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)
Time frame: Baseline and Day 45
Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega-3-acid Ethyl Esters | Change From Baseline of Lissamine Green Staining Score at Day 45 | 1.0 units on a scale |
| Corn Oil Capsule | Change From Baseline of Lissamine Green Staining Score at Day 45 | -1.0 units on a scale |
p-value: 0.44Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline of Schirmer-1 Test Value at Day 45
Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).
Time frame: Baseline and Day 45
Population: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omega-3-acid Ethyl Esters | Change From Baseline of Schirmer-1 Test Value at Day 45 | -2.5 millimeters |
| Corn Oil Capsule | Change From Baseline of Schirmer-1 Test Value at Day 45 | 1.0 millimeters |
p-value: 0.57Wilcoxon (Mann-Whitney)