Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study
Abstract Introduction This work aimed to evaluate the safety and efficacy of hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricating drops in Indian subjects with dry eye disease (DED). Methods This prospective, open-label, single-arm, phase IV study was conducted in India. Inclusion cr...
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Adis, Springer Healthcare
2024-12-01
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| Series: | Ophthalmology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40123-024-01069-9 |
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| author | Deborah Awisi-Gyau Neha Kapur Rajesh Parekh Umesh Yeddula Shreesha Kumar Kodavoor |
| author_facet | Deborah Awisi-Gyau Neha Kapur Rajesh Parekh Umesh Yeddula Shreesha Kumar Kodavoor |
| author_sort | Deborah Awisi-Gyau |
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| description | Abstract Introduction This work aimed to evaluate the safety and efficacy of hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricating drops in Indian subjects with dry eye disease (DED). Methods This prospective, open-label, single-arm, phase IV study was conducted in India. Inclusion criteria: Adults (18–65 years) with an average total ocular surface staining (TOSS) score ≥ 4, best-corrected visual acuity of ≥ 20/40 in each eye, tear break-up time (TBUT) ≤ 10 s, and dry eye questionnaire (DEQ-5) score ≥ 6. Subjects received the first dose of HPG-HA eye drops on day 1 and self-administered 1–2 drops four times daily for 90 ± 5 days. Primary endpoints: Frequency and characteristics of treatment-emergent adverse events (TEAEs) throughout the study and TOSS score at day 90. Secondary/other endpoints: Dry eye symptoms score (through dry eye questionnaire [DEQ-5]) and TBUT. Results Of 175 subjects, 36 (20.6%) had ≥ 1 TEAE, and 27 (15.4%) of this reported ≥ 1 mild drug-related TEAE (eye irritation [n = 9], eye pruritus [n = 8], blurred vision [n = 6], increased lacrimation [n = 4], ocular hyperemia [n = 3], and ocular discomfort [n = 1]). One subject discontinued due to TEAEs, and none led to drug interruptions. No serious adverse events were reported. The mean TOSS score reduced from day 1 (6.12 ± 1.69, OU [both eyes]) to day 90 (2.40 ± 1.97, OU). The mean DEQ-5 score reduced from day 1 (11.50 ± 2.27) to day 90 (5.50 ± 2.50). TBUT increased from day 1 (right eye [OD], 5.70 ± 1.94; left eye [OS], 5.70 ± 1.96) to day 90 (OD, 9.51 ± 3.08; OS, 9.63 ± 3.01). Conclusions HPG-HA dual-polymer eye drop was safe and effective in relieving signs and symptoms of DED over 90 days in Indian subjects. Trial Registration Clinical Trial Registry India, CTRI/2022/03/041175. |
| format | Article |
| id | doaj-art-6b410dd3c0ff4c3ba182cac3374df25b |
| institution | Kabale University |
| issn | 2193-8245 2193-6528 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Adis, Springer Healthcare |
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| series | Ophthalmology and Therapy |
| spelling | doaj-art-6b410dd3c0ff4c3ba182cac3374df25b2025-01-26T12:18:44ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282024-12-0114230932110.1007/s40123-024-01069-9Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV StudyDeborah Awisi-Gyau0Neha Kapur1Rajesh Parekh2Umesh Yeddula3Shreesha Kumar Kodavoor4Alcon Research LLCDr. Shroff’s Charity Eye HospitalBhagwan Mahaveer Jain HospitalSankara Eye HospitalThe Eye FoundationAbstract Introduction This work aimed to evaluate the safety and efficacy of hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricating drops in Indian subjects with dry eye disease (DED). Methods This prospective, open-label, single-arm, phase IV study was conducted in India. Inclusion criteria: Adults (18–65 years) with an average total ocular surface staining (TOSS) score ≥ 4, best-corrected visual acuity of ≥ 20/40 in each eye, tear break-up time (TBUT) ≤ 10 s, and dry eye questionnaire (DEQ-5) score ≥ 6. Subjects received the first dose of HPG-HA eye drops on day 1 and self-administered 1–2 drops four times daily for 90 ± 5 days. Primary endpoints: Frequency and characteristics of treatment-emergent adverse events (TEAEs) throughout the study and TOSS score at day 90. Secondary/other endpoints: Dry eye symptoms score (through dry eye questionnaire [DEQ-5]) and TBUT. Results Of 175 subjects, 36 (20.6%) had ≥ 1 TEAE, and 27 (15.4%) of this reported ≥ 1 mild drug-related TEAE (eye irritation [n = 9], eye pruritus [n = 8], blurred vision [n = 6], increased lacrimation [n = 4], ocular hyperemia [n = 3], and ocular discomfort [n = 1]). One subject discontinued due to TEAEs, and none led to drug interruptions. No serious adverse events were reported. The mean TOSS score reduced from day 1 (6.12 ± 1.69, OU [both eyes]) to day 90 (2.40 ± 1.97, OU). The mean DEQ-5 score reduced from day 1 (11.50 ± 2.27) to day 90 (5.50 ± 2.50). TBUT increased from day 1 (right eye [OD], 5.70 ± 1.94; left eye [OS], 5.70 ± 1.96) to day 90 (OD, 9.51 ± 3.08; OS, 9.63 ± 3.01). Conclusions HPG-HA dual-polymer eye drop was safe and effective in relieving signs and symptoms of DED over 90 days in Indian subjects. Trial Registration Clinical Trial Registry India, CTRI/2022/03/041175.https://doi.org/10.1007/s40123-024-01069-9Dry eye diseaseDry eye symptom scoreHydroxypropyl guar-hyaluronic acidTear break-up timeTotal ocular surface stainingTreatment-emergent adverse events |
| spellingShingle | Deborah Awisi-Gyau Neha Kapur Rajesh Parekh Umesh Yeddula Shreesha Kumar Kodavoor Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study Ophthalmology and Therapy Dry eye disease Dry eye symptom score Hydroxypropyl guar-hyaluronic acid Tear break-up time Total ocular surface staining Treatment-emergent adverse events |
| title | Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study |
| title_full | Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study |
| title_fullStr | Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study |
| title_full_unstemmed | Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study |
| title_short | Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study |
| title_sort | safety and efficacy of hydroxypropyl guar hyaluronic acid dual polymer lubricating eye drops in indian subjects with dry eye a phase iv study |
| topic | Dry eye disease Dry eye symptom score Hydroxypropyl guar-hyaluronic acid Tear break-up time Total ocular surface staining Treatment-emergent adverse events |
| url | https://doi.org/10.1007/s40123-024-01069-9 |
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