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| Name | Class |
|---|---|
| TearLab Corporation | INDUSTRY |
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Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications.
It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.
This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days |
|
| Hypromellose - standard treatment | Active Comparator | Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days |
|
| Combination treatment | Active Comparator | Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tear supplement | Other | Application as required to improve comfort |
|
| Measure | Description | Time Frame |
|---|---|---|
| Osmolarity change | Salt balance in tears measured with the Tearlab | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tear break-up time change | Tear stability following a blink | 3 months |
| Corneal staining change | Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Wolffsohn, BSc MBA PhD | Aston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Frith Opticians | Shaftesbury | Dorest | SP7 8AR | United Kingdom | ||
| Robert Frith Opticians |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| Tear supplement 2 | Other | Application as required to improve comfort |
|
|
| Omega 3 nutrition supplement | Dietary Supplement | Taken each day |
|
|
| Eye bag | Device | Applied following microwave heating to closed eyelids for 5 minutes each day |
|
|
| Saline | Other | Application as required to improve comfort |
|
|
| 3 months |
| Meibomian gland change | Grading of meibomian glands using Oxford scale | 3 months |
| Tear Meniscus Height | Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope | 3 months |
| SPEED Questionnaire change | Dry eye symptomology questionnaire | 3 months |
| Blandford Forum |
| Dorset |
| DT11 8AR |
| United Kingdom |
| Robert Frith Opticians | Gillingham | Dorset | SP8 4AA | United Kingdom |
| Robert Frith Opticians | Twickenham | Middlesex | TW1 4BW | United Kingdom |
| Black & Lizars Optometrists | Ayr | KA7 1UL | United Kingdom |
| Black & Lizars Optometrists | Glasgow | G46 6JB | United Kingdom |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |