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. 2024 Feb 27:45:101032.
doi: 10.1016/j.lanwpc.2024.101032. eCollection 2024 Apr.

Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial

Lei Tian  1 , Xiuming Jin  2 , Jibing Wang  3 , Yonggen Xu  4 , Chengwei Lu  5 , Shaozhen Zhao  6 , Qian Zhu  7 , Hong Dai  8 , Hao Gu  9 , Mingchang Zhang  10 , Linnong Wang  11 , Xiaohe Lu  12 , Lixiao Ma  13 , Lei Zhu  14 , Qingyan Zeng  15 , Hong Zhang  16 , Yao Fu  17 , Suxia Li  18 , Liming Tao  19 , Qian Ren  20 , Faming Ding  21 , Shenglin Zhang  21 , Shaopin Zhu  21 , Zhiping Li  21 , Ying Jie  1
Affiliations

Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial

Lei Tian et al. Lancet Reg Health West Pac. .

Abstract

Background: Dry eye disease has a high prevalence and exerts a significant negative effect on quality of life. In China, there are currently no available nasal sprays to promote natural tear production in patients with dry eye disease. We therefore evaluated the efficacy and safety of OC-01 (varenicline solution) nasal spray versus vehicle in Chinese patients with dry eye disease.

Methods: This was a randomized, multicenter, double-masked, vehicle-controlled, phase 3 clinical trial conducted at ophthalmology departments in 20 hospitals across China (NCT05378945). Eligible patients had a diagnosis of dry eye disease based on patient symptoms, Eye Dryness Score (EDS), Schirmer's Test (with topical anesthesia) Score (STS), and corneal fluorescein staining (CFS) score. Participants were randomly assigned 1:1 using an Interactive Web Response System (IWRS) to receive OC-01 0.6 mg/mL twice daily (BID) or vehicle nasal spray. Participants, investigators, and sponsor were all masked to treatment assignment. The primary endpoint was the percentage of subjects in the intention-to-treat population achieving ≥10 mm improvement in STS from baseline at week 4.

Findings: In total, 340 patients were randomized from 21 July 2022 to 04 April 2023, 78.8% were female. Patients in the OC-01 group (n = 176) had significantly higher achievement of ≥10 mm improvement in STS (35.8% [n = 63] versus 17.7% [n = 29], stratified odds ratio: 2.67, 95% CI: 1.570-4.533, p = 0.0002) and a significantly greater increase from baseline STS (least-squares mean difference [SE]: 3.87 [0.794], p < 0.0001) at week 4 versus the vehicle group (n = 164). In addition, OC-01 led to a numerically greater reduction in mean EDS from baseline at week 4 compared to the vehicle group (LS mean [SE] difference: -1.3 [2.20]; 95% CI: -5.64 to 2.99, p = 0.5467). The most common adverse event was mild, transient sneezing (78% of OC-01 administrations). No serious adverse events related to nasal administration occurred.

Interpretation: OC-01 (varenicline solution) nasal spray BID has clinically meaningful efficacy for reducing the signs (as measured by STS) and may improve the symptoms (as measured by EDS) of dry eye disease, with an excellent safety and tolerability profile, in the Chinese population.

Funding: Jixing Pharmaceutical Co. Ltd.

Keywords: Dry eye disease; Eye dryness score; Nicotinic acetylcholine receptor agonist; Randomized clinical trial; Schirmer's test score; Varenicline nasal spray.

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Conflict of interest statement

No conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Patient flow chart. aThe patient developed a foreign body sensation without the use of the study drug STS, Schirmer's Test Score.
Fig. 2
Fig. 2
The percentage of patients who achieved a ≥10 mm improvement in STS at Week 4 (ITT & mITT Population). STS, Schirmer's Test Score.
Fig. 3
Fig. 3
Mean change of STS at Week 4 from baseline (ITT & mITT Population). STS, Schirmer's Test Score.
Fig. 4
Fig. 4
Mean eye dryness score (mm).
Fig. 5
Fig. 5
Changes in dry eye disease signs (mITT Population and mITT per protocol).
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References

    1. Dry eye association China chapter, ocular surface and tear disease group of the ophthalmology professional committee of the cross-strait medical and health exchange association, ocular surface and dry eye group of the ophthalmologist branch of the Chinese medical doctor association. Chinese dry eye expert consensus: definition and classification (2020) Chin J Ophthalmol. 2020;56(6):418–422.
    1. Craig J.P., Nichols K.K., Akpek E.K., et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276–283. - PubMed
    1. Liu Z., Zhang X. Interpret the definition and classification of dry eye in the 2017 dry eye expert consensus of the international tear film and ocular surface association. Chin J Ophthalmol. 2018;54(4):246–248.
    1. Expert Consensus Expert Group on the Standardized Construction of Dry Eye Diagnosis and Treatment Centres. Dry Eye Rehabilitation Professional Group of Visual Rehabilitation Special Committee of Chinese Rehabilitation Medical Association Expert consensus on the standardization of dry eye diagnosis and treatment centres in China (2021) Chin J Exp Ophthalmol. 2021;39(6):473–476.
    1. Corneal Disease Group, Ophthalmology Branch of Chinese Medical Association Expert consensus on clinical diagnosis and treatment of dry eye (2013) Chin J Ophthalmol. 2013;49(1):73–75.

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