3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
NCT ID: NCT06903884
Last Updated: 2025-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
94 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-30
Study Completion Date
2028-12-31
Brief Summary
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The aim of the study is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution in terms of symptoms and signs of VKC, tear film metrics, ocular surface inflammation and quality of life. Potential beneficial effect of Diquafosol treatment on top of current standard use of topical immunosuppressant therapy in VKC would be studied.
Subject at least aged 6 and above with clinical diagnosis of vernal keratoconjunctivitis would be invited to join this study and perform the following assessments:
1. best corrected visual acuity,
2. slit lamp biomicroscope examination,
3. tear meniscus height and non-invasive keratographic tear breakup time(NIKBUT) measurement,
4. cornea fluorescein staining (CFS) and
5. Schirmer's I test. Doctor will prescribe eyedrop, 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion or 0.1% Cyclosporin A cationic ophthalmic emulsion at the end of examination. Subjects will be followed up at 4 weeks, 8 weeks, 16 weeks after treatment.
All participants will be required to answer a standardised questionnaire relating to severity of VKC and dry eye disease.
Subject at least aged 6 and above with clinical diagnosis of vernal keratoconjunctivitis would be invited to join this study and perform the following assessments:
1. best corrected visual acuity,
2. slit lamp biomicroscope examination,
3. tear meniscus height and non-invasive keratographic tear breakup time(NIKBUT) measurement,
4. cornea fluorescein staining (CFS) and
5. Schirmer's I test. Doctor will prescribe eyedrop, 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion or 0.1% Cyclosporin A cationic ophthalmic emulsion at the end of examination. Subjects will be followed up at 4 weeks, 8 weeks, 16 weeks after treatment.
All participants will be required to answer a standardised questionnaire relating to severity of VKC and dry eye disease.
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Detailed Description
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Aim To compare the four-month clinical efficacy of topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion versus 0.1% Cyclosporin A cationic ophthalmic emulsion in reducing symptoms and signs of active moderate-to-severe vernal keratoconjunctivitis (grade of 2 to 4 on the Bonini severity scale) with keratitis (corneal fluorescein staining score of 1-5 on the modified Oxford scale).
Study design A single-centre prospective double-blinded randomized controlled trial
Hypothesis The addition of topical treatment with 3% Diquafosol ophthalmic solution is superior to 0.1% Cyclosporin cationic ophthalmic emulsion alone in improving symptoms and signs of moderate-to-severe VKC with keratitis at four months of use.
Methods This is a single-centre, prospective, 16-week, randomized, double-blinded controlled clinical trial investigating the clinical efficacy and safety of combined topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion and versus topical treatment with 0.1% Cyclosporin A cationic ophthalmic emulsion in patients with moderate-to-severe vernal keratoconjunctivitis and keratitis. The study will also investigate the longitudinal changes in tear cytokines and correlate them with changes in VKC signs and tear film metrics. The study will be performed in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization, Good Clinical Practice guidelines, and all applicable laws and regulations. Written informed consent will be obtained from each patient before enrolment in the study. A clinical trials certificate will be obtained from the Department of Health, Hong Kong SAR.
Sample size The study will recruit 94 subjects with moderate-to-severe VKC at eye clinics in Hong Kong West cluster (QMH and GH).
Sample size Calculation Sample size calculation is based on the findings from a prospective study comparing the combined use of 3% Diquafosol and 0.1% Cyclosporin versus 0.1% Cyclosporin alone in the treatment of dry eye disease in 279 subjects \[36\]. It is anticipated that a similar, if not larger, effective size in VKC patients compared to dry eye patients would be seen. In this study the mean change in cornea staining score between baseline and week 12 was significantly higher in Cyclosporin A and Diquafosol combination therapy (2.91 ± 3.93) than in Cyclosporin A monotherapy (0.93± 2.22). The estimated Cohen's d for this study is approximately 0.620. Based on calculations, approximately 41 participants per group to achieve a study power of 80% with a significance level of 0.05 and the estimated effect size of 0.620 is needed. Considering a 10% dropout rate, the adjusted sample size per group would be approximately 47 participants.
Randomization method Randomisation is conducted by computer-generated random number allocation and will be applied to sequentially enrolled participants. The randomisation schedule is pre-determined, prior to commencing participant recruitment, such that the investigator involved in baseline participant assessment will have no involvement in treatment allocation. Block randomization is performed to ensure 1:1 distribution into treatment groups.
Double-blinding To keep the investigators and subjects blind to the study treatment, all investigational drugs are removed from their commercial packaging, wrapped in aluminium foil, double-wrapped in plastic bags, and distributed to participants by an independent clinical research coordinator.
Rescue Therapy During the study period rescue medication (Loteprednolol 0.5% one drop 4x/day for up to 5 days) is permitted in the event of worsening of ocular surface symptoms. A maximum of 2 courses were allowed between study visits. Any use of rescue therapy is documented in the eyedrop diary and serves as one of the outcome measures.
Patient Workflow The patient workflow is aimed at obtaining clear and comprehensive documentation of symptoms and signs baseline and each subsequent visit after initiation of intervention. Furthermore, documentation of adverse events is achieved via assessment of best corrected visual acuity, intraocular pressure measurement, general periorbital area assessment and slit lamp biomicroscope assessment. See Figure 1. Study Workflow
In particular, the sequence of clinical assessments must be done in order of sequence from least invasive to most invasive, as any touching of the ocular surface or manipulation of the eyelids will stimulate tear secretion. Least invasive tests include imaging-based assessments without manipulation or touching of the ocular surface, include best corrected visual acuity, slit lamp biomicroscope assessment, NIKBUT and tear meniscus height. Mildly invasive tests include those that require gentle touching of the ocular surface, such as fluorescein cornea staining. Moderately invasive tests include those with prolonged ocular surface contact, such as the Schirmer's I test for tear collection
Study design A single-centre prospective double-blinded randomized controlled trial
Hypothesis The addition of topical treatment with 3% Diquafosol ophthalmic solution is superior to 0.1% Cyclosporin cationic ophthalmic emulsion alone in improving symptoms and signs of moderate-to-severe VKC with keratitis at four months of use.
Methods This is a single-centre, prospective, 16-week, randomized, double-blinded controlled clinical trial investigating the clinical efficacy and safety of combined topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion and versus topical treatment with 0.1% Cyclosporin A cationic ophthalmic emulsion in patients with moderate-to-severe vernal keratoconjunctivitis and keratitis. The study will also investigate the longitudinal changes in tear cytokines and correlate them with changes in VKC signs and tear film metrics. The study will be performed in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization, Good Clinical Practice guidelines, and all applicable laws and regulations. Written informed consent will be obtained from each patient before enrolment in the study. A clinical trials certificate will be obtained from the Department of Health, Hong Kong SAR.
Sample size The study will recruit 94 subjects with moderate-to-severe VKC at eye clinics in Hong Kong West cluster (QMH and GH).
Sample size Calculation Sample size calculation is based on the findings from a prospective study comparing the combined use of 3% Diquafosol and 0.1% Cyclosporin versus 0.1% Cyclosporin alone in the treatment of dry eye disease in 279 subjects \[36\]. It is anticipated that a similar, if not larger, effective size in VKC patients compared to dry eye patients would be seen. In this study the mean change in cornea staining score between baseline and week 12 was significantly higher in Cyclosporin A and Diquafosol combination therapy (2.91 ± 3.93) than in Cyclosporin A monotherapy (0.93± 2.22). The estimated Cohen's d for this study is approximately 0.620. Based on calculations, approximately 41 participants per group to achieve a study power of 80% with a significance level of 0.05 and the estimated effect size of 0.620 is needed. Considering a 10% dropout rate, the adjusted sample size per group would be approximately 47 participants.
Randomization method Randomisation is conducted by computer-generated random number allocation and will be applied to sequentially enrolled participants. The randomisation schedule is pre-determined, prior to commencing participant recruitment, such that the investigator involved in baseline participant assessment will have no involvement in treatment allocation. Block randomization is performed to ensure 1:1 distribution into treatment groups.
Double-blinding To keep the investigators and subjects blind to the study treatment, all investigational drugs are removed from their commercial packaging, wrapped in aluminium foil, double-wrapped in plastic bags, and distributed to participants by an independent clinical research coordinator.
Rescue Therapy During the study period rescue medication (Loteprednolol 0.5% one drop 4x/day for up to 5 days) is permitted in the event of worsening of ocular surface symptoms. A maximum of 2 courses were allowed between study visits. Any use of rescue therapy is documented in the eyedrop diary and serves as one of the outcome measures.
Patient Workflow The patient workflow is aimed at obtaining clear and comprehensive documentation of symptoms and signs baseline and each subsequent visit after initiation of intervention. Furthermore, documentation of adverse events is achieved via assessment of best corrected visual acuity, intraocular pressure measurement, general periorbital area assessment and slit lamp biomicroscope assessment. See Figure 1. Study Workflow
In particular, the sequence of clinical assessments must be done in order of sequence from least invasive to most invasive, as any touching of the ocular surface or manipulation of the eyelids will stimulate tear secretion. Least invasive tests include imaging-based assessments without manipulation or touching of the ocular surface, include best corrected visual acuity, slit lamp biomicroscope assessment, NIKBUT and tear meniscus height. Mildly invasive tests include those that require gentle touching of the ocular surface, such as fluorescein cornea staining. Moderately invasive tests include those with prolonged ocular surface contact, such as the Schirmer's I test for tear collection
Conditions
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Vernal Keratoconjunctivitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
One group of subjects will receive topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion; another group of subjects will receive 0.1% Cyclosporin A cationic ophthalmic emulsion
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
It is a double-masked randomized study. Assigned treatment of a specific patients would be kept confidential in both the recruited participants and investigators. To keep the investigators and subjects blind to the study treatment, all investigational drugs are removed from their commercial packaging, wrapped in aluminium foil, double-wrapped in plastic bags, and distributed to participants by an independent clinical research coordinator.
Study Groups
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3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion
3% Diquafosol eyedrops 6x/day + 0.1% Cyclosporin A twice a day
Group Type
EXPERIMENTAL
3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion
Intervention Type
DRUG
This arm is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution
0.1% Cyclosporin A cationic ophthalmic emulsion
0.1% Cyclosporin A eyedrops twice a day + preservative free sodium hyaluronate eyedrops 6x/day
Group Type
ACTIVE_COMPARATOR
0.1% Cyclosporin A cationic ophthalmic emulsion
Intervention Type
DRUG
This arm is a control group to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution
Interventions
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3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion
This arm is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution
Intervention Type
DRUG
0.1% Cyclosporin A cationic ophthalmic emulsion
This arm is a control group to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Subject at least aged 6 and above
* Clinical diagnosis of vernal keratoconjunctivitis
* Evidence of active moderate-to-severe disease: At least Grade 2 on the Bonini scale of VKC clinical presentation (moderate-to-severe) \[38\].
* Evidence of keratitis: At least Grade 1 on the Modified Oxford scale for cornea fluorescein staining as reported by Bron et al \[39\].
* Experienced 1 or more recurrences of VKC during the previous year
* Clinical diagnosis of vernal keratoconjunctivitis
* Evidence of active moderate-to-severe disease: At least Grade 2 on the Bonini scale of VKC clinical presentation (moderate-to-severe) \[38\].
* Evidence of keratitis: At least Grade 1 on the Modified Oxford scale for cornea fluorescein staining as reported by Bron et al \[39\].
* Experienced 1 or more recurrences of VKC during the previous year
Exclusion Criteria
* Nasolacrimal duct obstruction
* Impaired blinking function
* Active ocular infection or history of ocular herpes, varicella zoster or vaccinia virus infection
* Any ocular disease that would require topical ocular treatment during the study
* Use of cyclosporin A or tacrolimus eyedrops, or use of systemic immunosuppressants within 3 months before enrolment
* Any ocular surgery within 6 months before enrolment
* Impaired blinking function
* Active ocular infection or history of ocular herpes, varicella zoster or vaccinia virus infection
* Any ocular disease that would require topical ocular treatment during the study
* Use of cyclosporin A or tacrolimus eyedrops, or use of systemic immunosuppressants within 3 months before enrolment
* Any ocular surgery within 6 months before enrolment
Minimum Eligible Age
6 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kendrick Co Shih
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong, Grantham Hospital
Central Contacts
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References
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Heikal MA, Soliman TT, Abousaif WS, Shebl AA. A comparative study between ciclosporine A eye drop (2%) and tacrolimus eye ointment (0.03%) in management of children with refractory vernal keratoconjunctivitis. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):353-361. doi: 10.1007/s00417-021-05356-0. Epub 2021 Aug 28.
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Sun X, Liu L, Liu C. Topical diquafosol versus hyaluronic acid for the treatment of dry eye disease: a meta-analysis of randomized controlled trials. Graefes Arch Clin Exp Ophthalmol. 2023 Dec;261(12):3355-3367. doi: 10.1007/s00417-023-06083-4. Epub 2023 May 10.
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Bonini S, Bonini S, Lambiase A, Marchi S, Pasqualetti P, Zuccaro O, Rama P, Magrini L, Juhas T, Bucci MG. Vernal keratoconjunctivitis revisited: a case series of 195 patients with long-term followup. Ophthalmology. 2000 Jun;107(6):1157-63. doi: 10.1016/s0161-6420(00)00092-0.
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Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
Reference Type
BACKGROUND
Other Identifiers
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VKC001
Identifier Type: -
Identifier Source: org_study_id
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NCT00987467
COMPLETED
NA
The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
NCT04668118
UNKNOWN
PHASE4
Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis
NCT00426023
COMPLETED
PHASE3
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
NCT00831662
COMPLETED
PHASE3
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)
NCT00328653
COMPLETED
PHASE2/PHASE3
Evaluation of the Efficacy and Safety of Tacrolimus Drops in Children With Vernal Keratoconjunctivitis
NCT05076084
COMPLETED
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
NCT03464435
COMPLETED
PHASE4
Diquafosol Ophthalmic Solution for Dry Eye Symptoms
NCT04980144
UNKNOWN
NA
Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK
NCT06852105
NOT_YET_RECRUITING
NA
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
NCT00884585
COMPLETED
PHASE3
Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
NCT01101984
COMPLETED
NA
Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis
NCT04376970
COMPLETED
PHASE4
Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
NCT07138742
NOT_YET_RECRUITING
NA
Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK
NCT07097922
NOT_YET_RECRUITING
NA
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
NCT00404131
COMPLETED
PHASE3
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
NCT00679718
COMPLETED
PHASE2
Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye Drops
NCT06172530
RECRUITING
Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation
NCT00349583
COMPLETED
PHASE4
Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease
NCT07297316
COMPLETED
PHASE4
Ditefossol Sodium 3% Eye Drops in Patients With Dry Eye
NCT06560580
COMPLETED
NA
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
NCT06329661
COMPLETED
PHASE4
Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease
NCT06876116
COMPLETED
PHASE4
A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
NCT06766357
RECRUITING
PHASE3
Diquafosol vs Hyaluronic Acid for Diabetic Dry Eye
NCT05682547
COMPLETED
NA
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
NCT00680108
COMPLETED
PHASE2