Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
* Drug: Sodium hyaluronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Optive Eyedrops | Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®<br>* Eyedrops as required, but at least 3 times per day<br>* Other names: Optive™ Eyedrops;|
| Active Comparator: 2<br>Hylocomod Eyedrops | Drug: Sodium hyaluronate<br>* Eyedrops as required, but at least 3 times per day<br>* Other names: Hylocomod;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | week 1, month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | week 1, month 1 | 
| 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) | week 1, month 1 | 
| Ocular Comfort and Ocular Symptoms on Visual Analogue Scale | Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent) | week 1, month 1 | 
| Daily Eyedrop Usage | Average daily eyedrop use | Month 1 | 
| Lipid Layer Pattern Assessment | Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer. | Week 1, month 1 |