A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease
Abstract Background The global prevalence of diabetes mellitus (DM) continues to rise and 70% of diabetic individuals have dry eye disease (DED) that leads to subsequent abnormalities of the corneal epithelium, corneal nerves, tear film, or corneal endothelium. In addition, persons with diabetes pro...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-12-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07818-8 |
| _version_ | 1797388049500340224 |
|---|---|
| author | Jiayan Chen Yimeng Chen Guanghao Qin Liangzhe Li Mingze Li Yuan Cheng Shuting Zhuang Zhihui Li Qing Zhang Yi Wu Lanting Yang Salissou Moutari Jonathan E. Moore Ling Xu Wei He Sile Yu Emmanuel Eric Pazo Xingru He |
| author_facet | Jiayan Chen Yimeng Chen Guanghao Qin Liangzhe Li Mingze Li Yuan Cheng Shuting Zhuang Zhihui Li Qing Zhang Yi Wu Lanting Yang Salissou Moutari Jonathan E. Moore Ling Xu Wei He Sile Yu Emmanuel Eric Pazo Xingru He |
| author_sort | Jiayan Chen |
| collection | DOAJ |
| description | Abstract Background The global prevalence of diabetes mellitus (DM) continues to rise and 70% of diabetic individuals have dry eye disease (DED) that leads to subsequent abnormalities of the corneal epithelium, corneal nerves, tear film, or corneal endothelium. In addition, persons with diabetes produce fewer tear secretions than healthy individuals. While several anti-inflammatory drug-based therapies for dry eye in diabetic individuals are currently being administered, their efficacy has not been studied in detail. Therefore, the aim of this study was to compare the effectiveness of 3% diquafosol (DQS) vs 0.1% hyaluronic acid (HA) eye drops in diabetic dry eye patients. Methods This triple-blind randomized, control trial will include 202 diabetic-related DED and will be assigned to DQS (n = 101) and HA (n = 101) one drop, six times per day for 8 weeks. Tear film lipid layer, non-invasive breakup time, conjunctivocorneal staining score, corneal sensitivity, tear MMP-9 levels, meibomian gland expression and quality, tear meniscus height, corneal nerves, immune/inflammatory cell change, conjunctival hyperemia, and ocular surface disease index questionnaire score will be assessed and compared at baseline, week 4, and week 8. Discussion This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of DQS and HA for diabetic dry eye treatment. Trial registration ClinicalTrials.govNCT05682547. Registered on December 05, 2022. |
| first_indexed | 2024-03-08T22:35:05Z |
| format | Article |
| id | doaj.art-2e83392c89c9474e9d7abd7eff26577b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T22:35:05Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2e83392c89c9474e9d7abd7eff26577b2023-12-17T12:29:13ZengBMCTrials1745-62152023-12-0124111210.1186/s13063-023-07818-8A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye diseaseJiayan Chen0Yimeng Chen1Guanghao Qin2Liangzhe Li3Mingze Li4Yuan Cheng5Shuting Zhuang6Zhihui Li7Qing Zhang8Yi Wu9Lanting Yang10Salissou Moutari11Jonathan E. Moore12Ling Xu13Wei He14Sile Yu15Emmanuel Eric Pazo16Xingru He17He Eye Specialist HospitalJinzhou Medical UniversityHe Eye Specialist HospitalHe Eye Specialist HospitalDalian Medical UniversityDalian Medical UniversityDalian Medical UniversityDalian Medical UniversityTianjin Medical UniversityChina Medical UniversityWenzhou Medical UniversityMathematical Sciences Research Centre, School of Mathematics and Physics, Queen’s University BelfastCathedral Eye ClinicHe Eye Specialist HospitalHe Eye Specialist HospitalHe UniversityHe Eye Specialist HospitalHe UniversityAbstract Background The global prevalence of diabetes mellitus (DM) continues to rise and 70% of diabetic individuals have dry eye disease (DED) that leads to subsequent abnormalities of the corneal epithelium, corneal nerves, tear film, or corneal endothelium. In addition, persons with diabetes produce fewer tear secretions than healthy individuals. While several anti-inflammatory drug-based therapies for dry eye in diabetic individuals are currently being administered, their efficacy has not been studied in detail. Therefore, the aim of this study was to compare the effectiveness of 3% diquafosol (DQS) vs 0.1% hyaluronic acid (HA) eye drops in diabetic dry eye patients. Methods This triple-blind randomized, control trial will include 202 diabetic-related DED and will be assigned to DQS (n = 101) and HA (n = 101) one drop, six times per day for 8 weeks. Tear film lipid layer, non-invasive breakup time, conjunctivocorneal staining score, corneal sensitivity, tear MMP-9 levels, meibomian gland expression and quality, tear meniscus height, corneal nerves, immune/inflammatory cell change, conjunctival hyperemia, and ocular surface disease index questionnaire score will be assessed and compared at baseline, week 4, and week 8. Discussion This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of DQS and HA for diabetic dry eye treatment. Trial registration ClinicalTrials.govNCT05682547. Registered on December 05, 2022.https://doi.org/10.1186/s13063-023-07818-8Diabetic dry eyeDry eye diseaseDiquafosolHyaluronic acidRandomized controlled trial |
| spellingShingle | Jiayan Chen Yimeng Chen Guanghao Qin Liangzhe Li Mingze Li Yuan Cheng Shuting Zhuang Zhihui Li Qing Zhang Yi Wu Lanting Yang Salissou Moutari Jonathan E. Moore Ling Xu Wei He Sile Yu Emmanuel Eric Pazo Xingru He A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease Trials Diabetic dry eye Dry eye disease Diquafosol Hyaluronic acid Randomized controlled trial |
| title | A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease |
| title_full | A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease |
| title_fullStr | A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease |
| title_full_unstemmed | A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease |
| title_short | A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease |
| title_sort | protocol for a single center randomized controlled trial comparing the clinical efficacy of 3 diquafosol and 0 1 hyaluronic acid in diabetic patients with dry eye disease |
| topic | Diabetic dry eye Dry eye disease Diquafosol Hyaluronic acid Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-023-07818-8 |
| work_keys_str_mv | AT jiayanchen aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT yimengchen aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT guanghaoqin aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT liangzheli aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT mingzeli aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT yuancheng aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT shutingzhuang aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT zhihuili aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT qingzhang aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT yiwu aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT lantingyang aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT salissoumoutari aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT jonathanemoore aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT lingxu aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT weihe aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT sileyu aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT emmanuelericpazo aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT xingruhe aprotocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT jiayanchen protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT yimengchen protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT guanghaoqin protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT liangzheli protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT mingzeli protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT yuancheng protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT shutingzhuang protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT zhihuili protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT qingzhang protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT yiwu protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT lantingyang protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT salissoumoutari protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT jonathanemoore protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT lingxu protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT weihe protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT sileyu protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT emmanuelericpazo protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease AT xingruhe protocolforasinglecenterrandomizedcontrolledtrialcomparingtheclinicalefficacyof3diquafosoland01hyaluronicacidindiabeticpatientswithdryeyedisease |