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The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TriMix | Experimental | A new-generation tear substitute containing cross-linked hyaluronic acid 0.15%, trehalose 3%, liposomes 1% and sterylamine 0.25%. |
|
| Hyaluronic acid | Active Comparator | 0.15% Hyaluronic acid tear substitute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimix tear substitutes | Drug | Patients were instructed to instill 1 drop of TriMix tear substitute into each eye 3 times per day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular surface disease index questionnaire | The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit. | This outcome measure was analyzed at baseline, 3 months and 6 months. |
| Non-invasive tear film break-up time | Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis. | This outcome measure was analyzed at baseline, 3 months and 6 months. |
| Schirmer I test without anesthesia | During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip. | This outcome measure was analyzed at baseline, 3 months and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José-MarÃa Sánchez-González | University of Seville | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novovision ophthalmologic clinic | Murcia | 30009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35567735 | Background | Vigo L, Senni C, Pellegrini M, Vagge A, Ferro Desideri L, Carones F, Scorcia V, Giannaccare G. Effects of a New Formulation of Multiple-Action Tear Substitute on Objective Ocular Surface Parameters and Ocular Discomfort Symptoms in Patients with Dry Eye Disease. Ophthalmol Ther. 2022 Aug;11(4):1441-1447. doi: 10.1007/s40123-022-00518-7. Epub 2022 May 14. | |
| 36498550 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2024 | Jun 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2024 | Jun 14, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Patients were instructed to instill 1 drop TriMix tear substitute or 0.15% HA tear substitute into each eye 3 times per day for 6 months. HA-based tear substitutes can reduce tear film hyperosmolarity and are effective in treating DED. Therefore, 0.15% HA tear substitute was selected as a suitable comparator.
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TriMix tear substitute and 0.15% HA tear substitute are transparent, with no special smell and the bottles were identical in appearance such that patients, investigators and care provider were masked to treatment assignment.
| Hyaluronic acid tear substitute | Drug | Patients were instructed to instill 1 drop of 0.15% HA tear substitute into each eye 3 times per day for 6 months. |
|
| Roszkowska AM, Inferrera L, Spinella R, Postorino EI, Gargano R, Oliverio GW, Aragona P. Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye. J Clin Med. 2022 Nov 26;11(23):6975. doi: 10.3390/jcm11236975. |