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An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhPRG4 450ug/ml | Experimental | rhPRG4 450ug/ml |
|
| Vehicle Control | Placebo Comparator | PBS Based Vehicle Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhPRG4 450ug/ml | Drug | Treatment |
| |
| Vehicle Control |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment | To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) compared to vehicle after 28 days of treatment | Baseline to day 28 |
| To assess the efficacy of rhPRG4 using the total VAS score (sum of dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia, anchors: none & severe) compared to vehicle after 28 days of treatment | To assess the efficacy of rhPRG4 using the total VAS score (sum of dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia, anchors: none & severe) compared to vehicle after 28 days of treatment | From baseline to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of rhPRG4 using individual VAS scores for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) compared to vehicle after 28 days of treatment | To assess the efficacy of rhPRG4 using individual VAS scores for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) compared to vehicle after 28 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection; 2. History of any ocular surgery (including laser or refractive surgical procedures) or therapeutic medical devices in either eye within 30 days before study enrollment. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization; Ocular surgery will not be allowed during study participation; 3. Initiation of new therapeutic modalities within 14 days of Visit 1; 4. Have a known hypersensitivity to one of the components of the study or procedural medications; 5. Have participated in another clinical study at the same time as the present study or within 30 days of the Visit 1; 6. Have a history of drug, medication or alcohol abuse or addiction; 7. Are females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) who meet any one of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward CEO | Contact | 6193394016 | ertruitt@lubris.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Eye Hospital | Not yet recruiting | Sydney | New South Wales | Australia |
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| Drug |
PBS Based Vehicle Control |
|
| From baseline to day 28 |
| To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment | To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle after 28 days of treatment | From baseline to day 28 |
| To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment | To assess the efficacy of rhPRG4 using the maximum inter-eye tear osmolarity: max(OU) compared to vehicle after 28 days of treatment | From baseline to day 28 |
| To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration | To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events over the study duration | From baseline to day 28 |
| To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA) | To assess the safety of rhPRG4 by observation of the Best Corrected Distance Visual Acuity (BCVA) | From baseline to day 28 |
| To assess the safety of rhPRG4 by observation of signs evaluated by safety examination (ophthalmic examination plus slit lamp examination (SLE) of meibomian glands, eyelid Erythema, eyelid oedema, lashes, conjunctival erythema, lens, iris, anterior chamb | To assess the safety of rhPRG4 by observation of signs evaluated by safety examination (ophthalmic examination plus slit lamp examination (SLE) of meibomian glands, eyelid Erythema, eyelid oedema, lashes, conjunctival erythema, lens, iris, anterior chamber, hyperemia, corneal transparency & corneal neovascularization) | From baseline to day 28 |
| To assess the safety of rhPRG4 by observation of intraocular pressure (IOP) | To assess the safety of rhPRG4 by observation of intraocular pressure (IOP) | From baseline to day 28 |
| OTA | Recruiting | Brisbane | Queensland | Australia |
|
| Royal Melbourne Hospital | Recruiting | Melbourne | Victoria | Australia |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |
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