Dry Eye
Conditions
Brief summary
This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
Interventions
DEVICEOptive® Fusion + Optive® Gel Drop
Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OSDI score of ≥ 23 * Ocular comfort at waking \<65 on 100-point scale * Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye * Use of eyedrops for the relief of dry eye symptoms for at least one month * Best corrected visual acuity in each eye of at least 20/25 * Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study * Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion criteria
* Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month * Use of Optive brand eyedrops in the last month * Monocular participants (only one eye with functional vision). * Contact lens wear during the study * History of herpetic keratitis, ocular surgery or irregular cornea; * Known pregnancy or lactation during the study period * Participation in any clinical trial within 30 days of the enrollment visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | Change from baseline to (day 30 +/- 3 days) | A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. |
| Measured Lissamine Green Bulbar Conjunctival Staining (mm2) | Change from baseline to (day 30 +/- 3 days) | The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Baseline (day 0) to (day 30 +/- 3 days) | The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Optive® Fusion™ and Optive® Gel Drop A CE marked eyedrop, containing 0.1% sodium hyaluronate, 0.5% carmellose sodium and 0.9% glycerol for daytime use. The eyedrop will be used as needed up to four times a day but at least twice a day and A CE marked gel, containing 0.5% carboxymethylcellulose sodium and 0.9% glycerol for night time use. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Optive® Fusion™ and Optive® Gel Drop |
|---|---|
| Age, Continuous | 52.13 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Time frame: Change from baseline to (day 30 +/- 3 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | -12.85 Scores on a scale | Standard Deviation 14.8 |
p-value: 0.00195% CI: [0.4395, 0.7204]t-test, 2 sided
Primary
Measured Lissamine Green Bulbar Conjunctival Staining (mm2)
The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).
Time frame: Change from baseline to (day 30 +/- 3 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optive® Fusion™ and Optive® Gel Drop | Measured Lissamine Green Bulbar Conjunctival Staining (mm2) | Nasal | 0.03 mm2 | Standard Deviation 0.04 |
| Optive® Fusion™ and Optive® Gel Drop | Measured Lissamine Green Bulbar Conjunctival Staining (mm2) | Temporal | 0.03 mm2 | Standard Deviation 0.08 |
Comparison: Nasalp-value: 0.025t-test, 1 sided
Comparison: Temporalp-value: 0.312t-test, 1 sided
Secondary
Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking
The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms.
Time frame: Baseline (day 0) to (day 30 +/- 3 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Comfort at Baseline | 30.22 scores on a scale | Standard Deviation 17.96 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Comfort at Day 30 | 58.02 scores on a scale | Standard Deviation 29.56 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Dry at Baseline | 59.08 scores on a scale | Standard Deviation 27.34 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Dry at Day 30 | 42.28 scores on a scale | Standard Deviation 32.74 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Gritty at Baseline | 52.95 scores on a scale | Standard Deviation 27.43 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Gritty at Day 30 | 31.09 scores on a scale | Standard Deviation 31.81 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Vision at Baseline | 49.00 scores on a scale | Standard Deviation 30.91 |
| Optive® Fusion™ and Optive® Gel Drop | Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking | Vision at Day 30 | 64.84 scores on a scale | Standard Deviation 29.98 |
Comparison: Comfortp-value: <0.001t-test, 1 sided
Comparison: Dryp-value: <0.001t-test, 1 sided
Comparison: Grittyp-value: <0.001t-test, 1 sided
Comparison: Visionp-value: <0.001t-test, 1 sided