Dry EyeNCT06537349
Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
A study testing 3% Diquafosol tetrasodium in people with Dry Eye, run by He Eye Hospital.
Trial summary
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- 3% Diquafosol tetrasodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-18 years old
- Wearing corneal shape mirror more than one year and at least eight hours every night
- Myopia -5.50 to -1.00 D, astigmatism < 1.75 D, or curvature between 41.00 and 46.00D, astigmatism < -0.75D, and best corrected visual acuity ≥1.0.
- Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score >13 points, and (b) NITBUT <10 s or (c) ocular surface dyeing assessment > 5 corneal spots/more than nine conjunctival spots.
- Participants were able to use eye drops as required, complete examinations, and return to the hospital for follow-up examinations within the specified time to complete follow-up.
Who cannot join
- Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
- Pathological changes in the corneal rim
- Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
- Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
- Have received any other eye treatment or surgery
Trial locations and contacts
No sites are listed yet.
About this study
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28
Read the detailed description
Keratoplasty is gaining popularity worldwide as a method of controlling myopia progression. Several clinical studies have shown that overnight wear of Orthokeratology lenses (OK) is an effective method of slowing myopia progression in adolescents.However, wearing corneal contact lenses tends to interfere with tear homeostasis, which may lead to ocular discomfort, dryness, and ocular surface disorders. More than 50% of contact lens wearers report symptoms of dry eye.Prolonged contact with the cornea can have an effect on the corneal layer.With the rapid increase in the use of OK lenses worldwide, potential complications have become a major concern for parents. Potential complications include keratitis and corneal epithelial damage. In addition, overnight OK lens wear has been associated with decreased tear production and reduced tear film stability. Recently, a four-week study by Carracedo et al. demonstrated that OK lens wear did not significantly change fluorescein-stained tear film breakup time or Schirmer's test I results, but subjects had increased dry eye symptoms one month after wear Decrease in cupped cell density.
Diquafosol Ophthalmic Solution (DQS) is a potent purinergic P2Y2 receptor agonist, a stabilized synthetic derivative of the naturally-occurring nucleotide uridine 5'-triphosphate; it stimulates the secretion of mucin and tears by conjunctival cup cells and conjunctival epithelial cells. Several studies have shown that Diquafosol sodium is effective in the treatment of dry eye. In addition, some studies have shown that Diquafosol sodium eye drops have significantly alleviated dry eye symptoms and improved ocular surface parameters in children wearing keratomileusis lenses at night. However, the available research lacks the ability of the DQS to assess the effect of DQS on visual acuity and quality of life improvement in patients with dry eye after wearing OK lenses. The results would inform clinicians to improve comfort and compliance with keratoplasty lenses in adolescents.
- Conditions
- Dry Eye
- Being tested
- 3% Diquafosol tetrasodium
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Diquafosol tetrasodiumDrug
Also called Diquas
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in OK lens related dry eye
| Study group | Role | What they receive |
|---|---|---|
| DQS group | Experimental | Participants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co.,Ltd., Osaka, Japan) six times per day for 4 weeks Receives: Drug: 3% Diquafosol tetrasodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Refractive Error Profile(PREP) questionnaire score
Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Secondary outcomes (6)
Non-invasive tear break-up time
Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Tear Film Lipid Layer
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Conjunctivocorneal staining grade
Using fluorescein sodium solution or fluorescein sodium test paper to contact the lower eyelid margin, corneal and conjunctival epithelial defects under the cobalt blue light of the slit lamp microscope showed different morphology, such as green spots, erosion, lamellar defects, ulcers and so on. The following categories: according to the severity of the symptoms can be mild, slit lamp microscope check no obvious signs of ocular surface damage (corneal fluorescein staining point < 5); Moderate: the extent of corneal damage under the slit lamp microscope did not exceed 2 quadrants and (or) the number of corneal fluorescein staining spots was >5 and <30. Severe: the range of corneal damage was 2 quadrants or more and (or) the corneal fluorescent staining spots were more than 30. The fluorescein staining spots in the cornea fused into thick spots, sheets or with filaments.
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Tear meniscus height
Changes in TMH will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Ocular Surface Disease Index(OSDI) questionnaire score
the Chinese language-validated OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms, and any condition associated with DED, will be used. Te patient will answer each question on a scale ranging from 0 to 4, with 0 indicating "none of the time" and 4 indicating "all of the time." If a certain question is deemed irrelevant, it will be marked as "not applicable (N/A)" and excluded from the analysis. The OSDI total score is calculated according to the proprietary formula proposed by the authors of the original OSDI. The scale ranges from 0 to 100, with higher scores representing more severe cases of DED.
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Objective visual quality assessment
Using SCHWIND SIRIUS eyes analyzer objective visual quality assessment, including: total higher-order aberrations, spherical aberration, coma makes, clover, and RMS values etc..
Measured: Day-0 (baseline), 2-weeks, 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537349
- Sponsor's protocol ID
- DQS2024
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.
PubMed 23645372Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
PubMed 24003088Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
PubMed 21212181Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
PubMed 27391535Han X, Xu D, Ge W, Wang Z, Li X, Liu W. A Comparison of the Effects of Orthokeratology Lens, Medcall Lens, and Ordinary Frame Glasses on the Accommodative Response in Myopic Children. Eye Contact Lens. 2018 Jul;44(4):268-271. doi: 10.1097/ICL.0000000000000390.
PubMed 28617728Li J, Dong P, Liu H. Effect of Overnight Wear Orthokeratology Lenses on Corneal Shape and Tears. Eye Contact Lens. 2018 Sep;44(5):304-307. doi: 10.1097/ICL.0000000000000357.
PubMed 28060144Carracedo G, Martin-Gil A, Fonseca B, Pintor J. Effect of overnight orthokeratology on conjunctival goblet cells. Cont Lens Anterior Eye. 2016 Aug;39(4):266-9. doi: 10.1016/j.clae.2016.04.001. Epub 2016 Apr 13.
PubMed 27085466Li Y, Kuang K, Yerxa B, Wen Q, Rosskothen H, Fischbarg J. Rabbit conjunctival epithelium transports fluid, and P2Y2(2) receptor agonists stimulate Cl(-) and fluid secretion. Am J Physiol Cell Physiol. 2001 Aug;281(2):C595-602. doi: 10.1152/ajpcell.2001.281.2.C595.
PubMed 11443059Ishikawa S, Sasaki T, Maruyama T, Murayama K, Shinoda K. Effectiveness and Adherence of Dry Eye Patients Who Switched from Short- to Long-Acting Diquafosol Ophthalmic Solution. J Clin Med. 2023 Jul 5;12(13):4495. doi: 10.3390/jcm12134495.
PubMed 37445527Keating GM. Diquafosol ophthalmic solution 3 %: a review of its use in dry eye. Drugs. 2015 May;75(8):911-22. doi: 10.1007/s40265-015-0409-7.
PubMed 25968930Amano S, Inoue K. Effect of topical 3% diquafosol sodium on eyes with dry eye disease and meibomian gland dysfunction. Clin Ophthalmol. 2017 Sep 14;11:1677-1682. doi: 10.2147/OPTH.S148167. eCollection 2017.
PubMed 29075094Ji YW, Kim HM, Ryu SY, Oh JW, Yeo A, Choi CY, Kim MJ, Song JS, Kim HS, Seo KY, Kim KP, Lee HK. Changes in Human Tear Proteome Following Topical Treatment of Dry Eye Disease: Cyclosporine A Versus Diquafosol Tetrasodium. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):5035-5044. doi: 10.1167/iovs.19-27872.
PubMed 31800960Kaido M, Kawashima M, Shigeno Y, Yamada Y, Tsubota K. Randomized Controlled Study to Investigate the Effect of Topical Diquafosol Tetrasodium on Corneal Sensitivity in Short Tear Break-Up Time Dry Eye. Adv Ther. 2018 May;35(5):697-706. doi: 10.1007/s12325-018-0685-1. Epub 2018 Apr 18.
PubMed 29671255Yang Y, Wu Q, Tang Y, Wu H, Luo Z, Gao W, Hu Z, Hou L, Wang M, Yang Z, Li X. Short-term application of diquafosol ophthalmic solution benefits children with dry eye wearing orthokeratology lens. Front Med (Lausanne). 2023 Jul 13;10:1130117. doi: 10.3389/fmed.2023.1130117. eCollection 2023.
PubMed 37521335
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
- ClinicalTrials.gov ID
- NCT06537349
- Acronym / sponsor ID
- DQS2024
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28
Detailed description
Keratoplasty is gaining popularity worldwide as a method of controlling myopia progression. Several clinical studies have shown that overnight wear of Orthokeratology lenses (OK) is an effective method of slowing myopia progression in adolescents.However, wearing corneal contact lenses tends to interfere with tear homeostasis, which may lead to ocular discomfort, dryness, and ocular surface disorders. More than 50% of contact lens wearers report symptoms of dry eye.Prolonged contact with the cornea can have an effect on the corneal layer.With the rapid increase in the use of OK lenses worldwide, potential complications have become a major concern for parents. Potential complications include keratitis and corneal epithelial damage. In addition, overnight OK lens wear has been associated with decreased tear production and reduced tear film stability. Recently, a four-week study by Carracedo et al. demonstrated that OK lens wear did not significantly change fluorescein-stained tear film breakup time or Schirmer's test I results, but subjects had increased dry eye symptoms one month after wear Decrease in cupped cell density.
Diquafosol Ophthalmic Solution (DQS) is a potent purinergic P2Y2 receptor agonist, a stabilized synthetic derivative of the naturally-occurring nucleotide uridine 5'-triphosphate; it stimulates the secretion of mucin and tears by conjunctival cup cells and conjunctival epithelial cells. Several studies have shown that Diquafosol sodium is effective in the treatment of dry eye. In addition, some studies have shown that Diquafosol sodium eye drops have significantly alleviated dry eye symptoms and improved ocular surface parameters in children wearing keratomileusis lenses at night. However, the available research lacks the ability of the DQS to assess the effect of DQS on visual acuity and quality of life improvement in patients with dry eye after wearing OK lenses. The results would inform clinicians to improve comfort and compliance with keratoplasty lenses in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DQS group | Experimental | Drug: 3% Diquafosol tetrasodiumParticipants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co.,Ltd., Osaka, Japan) six times per day for 4 weeks |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 8-18 years old
- Wearing corneal shape mirror more than one year and at least eight hours every night
- Myopia -5.50 to -1.00 D, astigmatism < 1.75 D, or curvature between 41.00 and 46.00D, astigmatism < -0.75D, and best corrected visual acuity ≥1.0.
- Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score >13 points, and (b) NITBUT <10 s or (c) ocular surface dyeing assessment > 5 corneal spots/more than nine conjunctival spots.
- Participants were able to use eye drops as required, complete examinations, and return to the hospital for follow-up examinations within the specified time to complete follow-up.
Key exclusion criteria (5 listed)
- Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
- Pathological changes in the corneal rim
- Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
- Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
- Have received any other eye treatment or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% Diquafosol tetrasodiumAlso: Diquas3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in OK lens related dry eye | Drug | DQS group |
Primary outcome
Pediatric Refractive Error Profile(PREP) questionnaire score
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.
6 secondary outcomes
Non-invasive tear break-up time
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Tear Film Lipid Layer
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Conjunctivocorneal staining grade
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Tear meniscus height
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Ocular Surface Disease Index(OSDI) questionnaire score
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Objective visual quality assessment
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 23645372Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.
- Background: PubMed 24003088Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
- Background: PubMed 21212181Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
- Background: PubMed 27391535Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
- Background: PubMed 28617728Han X, Xu D, Ge W, Wang Z, Li X, Liu W. A Comparison of the Effects of Orthokeratology Lens, Medcall Lens, and Ordinary Frame Glasses on the Accommodative Response in Myopic Children. Eye Contact Lens. 2018 Jul;44(4):268-271. doi: 10.1097/ICL.0000000000000390.
- Background: PubMed 28060144Li J, Dong P, Liu H. Effect of Overnight Wear Orthokeratology Lenses on Corneal Shape and Tears. Eye Contact Lens. 2018 Sep;44(5):304-307. doi: 10.1097/ICL.0000000000000357.
- Background: PubMed 27085466Carracedo G, Martin-Gil A, Fonseca B, Pintor J. Effect of overnight orthokeratology on conjunctival goblet cells. Cont Lens Anterior Eye. 2016 Aug;39(4):266-9. doi: 10.1016/j.clae.2016.04.001. Epub 2016 Apr 13.
- Background: PubMed 11443059Li Y, Kuang K, Yerxa B, Wen Q, Rosskothen H, Fischbarg J. Rabbit conjunctival epithelium transports fluid, and P2Y2(2) receptor agonists stimulate Cl(-) and fluid secretion. Am J Physiol Cell Physiol. 2001 Aug;281(2):C595-602. doi: 10.1152/ajpcell.2001.281.2.C595.
- Background: PubMed 37445527Ishikawa S, Sasaki T, Maruyama T, Murayama K, Shinoda K. Effectiveness and Adherence of Dry Eye Patients Who Switched from Short- to Long-Acting Diquafosol Ophthalmic Solution. J Clin Med. 2023 Jul 5;12(13):4495. doi: 10.3390/jcm12134495.
- Background: PubMed 25968930Keating GM. Diquafosol ophthalmic solution 3 %: a review of its use in dry eye. Drugs. 2015 May;75(8):911-22. doi: 10.1007/s40265-015-0409-7.
- Background: PubMed 29075094Amano S, Inoue K. Effect of topical 3% diquafosol sodium on eyes with dry eye disease and meibomian gland dysfunction. Clin Ophthalmol. 2017 Sep 14;11:1677-1682. doi: 10.2147/OPTH.S148167. eCollection 2017.
- Background: PubMed 31800960Ji YW, Kim HM, Ryu SY, Oh JW, Yeo A, Choi CY, Kim MJ, Song JS, Kim HS, Seo KY, Kim KP, Lee HK. Changes in Human Tear Proteome Following Topical Treatment of Dry Eye Disease: Cyclosporine A Versus Diquafosol Tetrasodium. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):5035-5044. doi: 10.1167/iovs.19-27872.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing 3% Diquafosol tetrasodium in people with Dry Eye, run by He Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayan Chen (18304019060, cjy100009@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Refractive Error Profile(PREP) questionnaire score (time frame: Day-0 (baseline), 2-weeks, 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537349, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.