Dry Eye Syndromes
Conditions
Brief summary
This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.
Interventions
DRUGA sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Eyedrops as required, but at least 3 times per day
DRUGSodium hyaluronate
Eyedrops as required, but at least 3 times per day
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or over * Contact lens wearer, spectacle wearer or non-spectacle wearer * Mild to severe dry eye symptoms, defined as OSDI score 13 to 100 * Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye * Best corrected visual acuity of 6/9 in each eye
Exclusion criteria
* Previously used Hylocomod or Optive eyedrops * Systemic allergy or eye allergy * Systemic disease which might have an ocular component and/or interfere with contact lens wear * Autoimmune disease which might have an ocular component and/or interfere with contact lens wear * Systemic medication which might have eye side effects and or interfere with contact lens wear * Eye infection or use of eye medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Staining by Lissamine Green | week 1, month 1 | Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining by Fluorescein | week 1, month 1 | Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe) |
| Conjunctival Hyperaemia | week 1, month 1 | Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness) |
| Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | week 1, month 1 | Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent) |
| Daily Eyedrop Usage | Month 1 | Average daily eyedrop use |
| Lipid Layer Pattern Assessment | Week 1, month 1 | Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboxymethylcellulose and Glycerin | 21 |
| Sodium Hyaluronate | 26 |
| Total | 47 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose and Glycerin | Sodium Hyaluronate | Total |
|---|---|---|---|
| Age Continuous | 44.8 years STANDARD_DEVIATION 16.4 | 39.9 years STANDARD_DEVIATION 14.8 | 42.0 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 21 | 2 / 26 |
| serious Total, serious adverse events | 0 / 21 | 0 / 26 |
Outcome results
Primary
Conjunctival Staining by Lissamine Green
Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Time frame: week 1, month 1
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Week 1 - None | 50.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Week 1 - Trace | 17.5 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Week 1 - Mild | 17.5 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Week 1 - Moderate | 15.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Week 1 - Severe | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Month 1 - None | 78.6 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Month 1 - Trace | 11.9 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Month 1 - Mild | 9.5 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Month 1 - Moderate | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Staining by Lissamine Green | Month 1 - Severe | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Month 1 - Mild | 25.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Week 1 - None | 53.8 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Month 1 - None | 50.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Week 1 - Trace | 15.4 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Month 1 - Severe | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Week 1 - Mild | 25.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Month 1 - Trace | 17.3 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Week 1 - Moderate | 5.8 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Month 1 - Moderate | 7.7 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Staining by Lissamine Green | Week 1 - Severe | 0.0 Percentage of Participants |
Secondary
Conjunctival Hyperaemia
Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
Time frame: week 1, month 1
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Week 1 - Clear/White | 5.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Week 1 - Slight | 75.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Week 1 - Mild | 17.5 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Week 1 - Moderate | 2.5 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Week 1 - Severe | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Month 1 - Clear/White | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Month 1 - Slight | 71.4 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Month 1 - Mild | 28.6 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Month 1 - Moderate | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Conjunctival Hyperaemia | Month 1 - Severe | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Month 1 - Mild | 28.8 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Week 1 - Clear/White | 3.8 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Month 1 - Clear/White | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Week 1 - Slight | 59.6 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Month 1 - Severe | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Week 1 - Mild | 36.5 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Month 1 - Slight | 71.2 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Week 1 - Moderate | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Month 1 - Moderate | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Conjunctival Hyperaemia | Week 1 - Severe | 0.0 Percentage of Participants |
Secondary
Corneal Staining by Fluorescein
Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Time frame: week 1, month 1
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Week 1 - None | 45.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Week 1 - Trace | 25.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Week 1 - Mild | 15.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Week 1 - Moderate | 15.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Week 1 - Severe | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Month 1 - None | 73.8 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Month 1 - Trace | 21.4 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Month 1 - Mild | 4.8 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Month 1 - Moderate | 0.0 Percentage of Participants |
| Carboxymethylcellulose and Glycerin | Corneal Staining by Fluorescein | Month 1 - Severe | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Month 1 - Mild | 26.9 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Week 1 - None | 57.7 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Month 1 - None | 51.9 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Week 1 - Trace | 15.4 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Month 1 - Severe | 0.0 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Week 1 - Mild | 25.0 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Month 1 - Trace | 15.4 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Week 1 - Moderate | 1.9 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Month 1 - Moderate | 5.8 Percentage of Participants |
| Sodium Hyaluronate | Corneal Staining by Fluorescein | Week 1 - Severe | 0.0 Percentage of Participants |
Secondary
Daily Eyedrop Usage
Average daily eyedrop use
Time frame: Month 1
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin | Daily Eyedrop Usage | 3.7 drops/day | Standard Deviation 1.4 |
| Sodium Hyaluronate | Daily Eyedrop Usage | 3.3 drops/day | Standard Deviation 1 |
Secondary
Lipid Layer Pattern Assessment
Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
Time frame: Week 1, month 1
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin | Lipid Layer Pattern Assessment | Week 1 | 4.50 Lipid Layer Mixing Pattern |
| Carboxymethylcellulose and Glycerin | Lipid Layer Pattern Assessment | Month 1 | 3.00 Lipid Layer Mixing Pattern |
| Sodium Hyaluronate | Lipid Layer Pattern Assessment | Week 1 | 5.50 Lipid Layer Mixing Pattern |
| Sodium Hyaluronate | Lipid Layer Pattern Assessment | Month 1 | 5.00 Lipid Layer Mixing Pattern |
Secondary
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Time frame: week 1, month 1
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Daytime (Wk.1) | 63.20 Units on a scale | Standard Deviation 22.05 |
| Carboxymethylcellulose and Glycerin | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Waking (Mo.1) | 65.05 Units on a scale | Standard Deviation 23.48 |
| Carboxymethylcellulose and Glycerin | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Waking (Wk.1) | 67.05 Units on a scale | Standard Deviation 24.9 |
| Carboxymethylcellulose and Glycerin | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Evening (Wk.1) | 57.15 Units on a scale | Standard Deviation 26.3 |
| Carboxymethylcellulose and Glycerin | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Evening (Mo.1) | 60.38 Units on a scale | Standard Deviation 23.29 |
| Carboxymethylcellulose and Glycerin | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Daytime (Mo.1) | 68.57 Units on a scale | Standard Deviation 17.25 |
| Sodium Hyaluronate | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Evening (Mo.1) | 65.06 Units on a scale | Standard Deviation 23.44 |
| Sodium Hyaluronate | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Waking (Wk.1) | 58.81 Units on a scale | Standard Deviation 24.73 |
| Sodium Hyaluronate | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Daytime (Wk.1) | 68.21 Units on a scale | Standard Deviation 19.48 |
| Sodium Hyaluronate | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Evening (Wk.1) | 63.38 Units on a scale | Standard Deviation 23.71 |
| Sodium Hyaluronate | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Waking (Mo.1) | 63.56 Units on a scale | Standard Deviation 28.79 |
| Sodium Hyaluronate | Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Ocular Comfort - Daytime (Mo.1) | 70.48 Units on a scale | Standard Deviation 23.21 |