Dry Eye SyndromePhase 4NCT03666884
The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome
A Phase 4 study testing COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 and AS 50% eye drops 8*1 in people with Dry Eye Syndrome, run by Seref istek.
Trial summary
The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 and AS 50% eye drops 8*1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2015to 25 Oct 2016
- Phase
- Phase 4
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives)
- had low TBUT (< 5 s) (5μL of fluorescein sodium 2% eye drops was used)
- low Schirmer's test I score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the OXFORD Scale) (3) and an OSDI score > 40 OSDI was a reliable and valid test for quantifying the severity of dry eye symptoms
Who cannot join
- active ocular infection or any other inflammation not associated with dry eye
- a severe associated ocular allergy, eyelid or eyelash abnormality
- current contact lens use, history of refractive surgery
- associated glaucoma
- current use of any type of topical eye drops other than dry eye medications
- any known graft-versus host disease
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- known severe anemia (hemoglobin<11 g/dL-1)
- medically uncontrolled significant cerebrovascular and cardiovascular disease
- pregnant and lactating patients
About this study
Official title: The Comparison of 50 % Concentration Autologous Serum Eye Drops Versus Preservative Free Artificial Eye Drop Plus 0.05 % Cyclosporin Ophthalmic Emulsion in the Treatment of Severe Dry Eye Syndrome: A Randomized Comparative Study
The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE treatment in patients with severe DES
Read the detailed description
This is an retrospective comparative study. The designation of the patient whether to use AS 8*1 or conventional PFAT 8*1 plus COE 2*1 was determined randomly. Student's paired samples t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U test were used to compare data. All patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment OSDI scores, Schirmer's test results, TBUT values, and OXFORD scale scores.
- Conditions
- Dry Eye Syndrome
- Being tested
- COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1, AS 50% eye drops 8*1
- Keywords
- dry eye, autologous serum, cyclosporine ophthalmic emulsion
- 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.
COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1Drug
Also called Restasis+Refresh Single Dose
clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
AS 50% eye drops 8*1Biological
Also called 50% autologous serum eye drops 8*1
clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
| Study group | Role | What they receive |
|---|---|---|
| dry eye patients 1 | Active comparator | dry eye patients treated for 1 month and patient symptoms after 1 month Receives: Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1; Biological: AS 50% eye drops 8*1 |
| dry eye patients 2 | Active comparator | dry eye patients treated for 1 month and patient symptoms after 1 month Receives: Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1; Biological: AS 50% eye drops 8*1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
schirmers test 1 result
clinical improvement in schirmer's test 1 result
Measured: first month results after two treatment regimes for severe dry eye groupes, 5 minutes tear drop wetness of schirmers paper in milimeters
ocular surface oxford scale
clinical improvement in oxford scale
Measured: first month results after two treatment regimes for severe dry eye groupes, dry eye symptom scale graded 1 to 4
ocular surface disease index scale (OSDI)
clinical improvement in OSDI
Measured: first month results after two treatment regimes for severe dry eye groupes, dry eye symptoms graduation prepared with sample questions concluded in 2 digit numbers from 25 to 100,
tear break up time
clinical improvement in tear break up time
Measured: first month results after two treatment regimes for severe dry eye groupes, dry eye quantitave assesment of tear break up time in seconds graded from 0 sec to 10 seconds 10 the best 0 the worst
fluorescein staining of eye
clinical improvement in fluorescein staining of eye
Measured: first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start10 Oct 2015
- Primary completion15 Mar 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The comparison of 50 % concentration autologous serum eye drops versus preservative free artificial eye drop plus 0.05 % cyclosporin ophthalmic emulsion in the treatment of severe dry eye syndrom
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seref istek
- Sponsor type
- University, hospital or other
- Collaborators
- Usak State Hospital
- Responsible party
- Sponsor-investigator, Seref istek, Usak State Hospital
- Investigators
- şeref istek, doctor, Principal investigator, Department of Ophtalmology, Usak State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666884
- Sponsor's protocol ID
- UsakSH
- Status last verified
- Sep 2018
- First submitted
- 20 Feb 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: study data can be shared
Publications
Bradley JC, Bradley RH, McCartney DL, Mannis MJ. Serum growth factor analysis in dry eye syndrome. Clin Exp Ophthalmol. 2008 Nov;36(8):717-20. doi: 10.1111/j.1442-9071.2008.01895.x.
PubMed 19128374Research in dry eye: report of the Research Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):179-93. doi: 10.1016/s1542-0124(12)70086-1.
PubMed 17508121Bron 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.
PubMed 14508260Pflugfelder SC, Solomon A, Stern ME. The diagnosis and management of dry eye: a twenty-five-year review. Cornea. 2000 Sep;19(5):644-9. doi: 10.1097/00003226-200009000-00009.
PubMed 11009316Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.
PubMed 6712760Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjogren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5. doi: 10.1136/bjo.83.4.390.
PubMed 10434857Lopez-Garcia JS, Garcia-Lozano I, Rivas L, Martinez-Garchitorena J. [Use of autologous serum in ophthalmic practice]. Arch Soc Esp Oftalmol. 2007 Jan;82(1):9-20. doi: 10.4321/s0365-66912007000100004. Spanish.
PubMed 17262232Rybickova I, Vesela V, Fales I, Skalicka P, Jirsova K. Apoptosis of conjunctival epithelial cells before and after the application of autologous serum eye drops in severe dry eye disease. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):271-5. doi: 10.5507/bp.2016.001. Epub 2016 Feb 29.
PubMed 26927466Gao J, Schwalb TA, Addeo JV, Ghosn CR, Stern ME. The role of apoptosis in the pathogenesis of canine keratoconjunctivitis sicca: the effect of topical Cyclosporin A therapy. Cornea. 1998 Nov;17(6):654-63. doi: 10.1097/00003226-199811000-00014.
PubMed 9820947Ridder WH 3rd. Ciclosporin use in dry eye disease patients. Expert Opin Pharmacother. 2008 Dec;9(17):3121-8. doi: 10.1517/14656560802500613.
PubMed 19006483Yuksel B, Bozdag B, Acar M, Topaloglu E. Evaluation of the effect of topical cyclosporine A with impression cytology in dry eye patients. Eur J Ophthalmol. 2010 Jul-Aug;20(4):675-9. doi: 10.1177/112067211002000405.
PubMed 20155706Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjogren's Syndrome. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. doi: 10.1136/ard.61.6.554.
PubMed 12006334Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
PubMed 10815152Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6. doi: 10.1016/j.ajo.2004.08.040.
PubMed 15733983Tananuvat N, Daniell M, Sullivan LJ, Yi Q, McKelvie P, McCarty DJ, Taylor HR. Controlled study of the use of autologous serum in dry eye patients. Cornea. 2001 Nov;20(8):802-6. doi: 10.1097/00003226-200111000-00005.
PubMed 11685055
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of 50 % Concentration Autologous Serum Eye Drops Versus Preservative Free Artificial Eye Drop Plus 0.05 % Cyclosporin Ophthalmic Emulsion in the Treatment of Severe Dry Eye Syndrome: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT03666884
- Acronym / sponsor ID
- UsakSH
- Conditions
- Dry Eye Syndrome
- Keywords
- dry eye, autologous serum, cyclosporine ophthalmic emulsion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seref istekUniversity, hospital or other
- Collaborators
- Usak State Hospital
- Study start
- 10 Oct 2015 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 12 Sep 2018 (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.
The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE treatment in patients with severe DES
Detailed description
This is an retrospective comparative study. The designation of the patient whether to use AS 8*1 or conventional PFAT 8*1 plus COE 2*1 was determined randomly. Student's paired samples t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U test were used to compare data. All patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment OSDI scores, Schirmer's test results, TBUT values, and OXFORD scale scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The comparison of 50 % concentration autologous serum eye drops versus preservative free artificial eye drop plus 0.05 % cyclosporin ophthalmic emulsion in the treatment of severe dry eye syndrom
| Arm | Type | Receives |
|---|---|---|
| dry eye patients 1 | Active comparator | Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1, Biological: AS 50% eye drops 8*1dry eye patients treated for 1 month and patient symptoms after 1 month |
| dry eye patients 2 | Active comparator | Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1, Biological: AS 50% eye drops 8*1dry eye patients treated for 1 month and patient symptoms after 1 month |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives)
- had low TBUT (< 5 s) (5μL of fluorescein sodium 2% eye drops was used)
- low Schirmer's test I score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the OXFORD Scale) (3) and an OSDI score > 40 OSDI was a reliable and valid test for quantifying the severity of dry eye symptoms
Key exclusion criteria (9 listed)
- active ocular infection or any other inflammation not associated with dry eye
- a severe associated ocular allergy, eyelid or eyelash abnormality
- current contact lens use, history of refractive surgery
- associated glaucoma
- current use of any type of topical eye drops other than dry eye medications
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 |
|---|---|---|
| COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1Also: Restasis+Refresh Single Doseclinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye | Drug | dry eye patients 1, dry eye patients 2 |
| AS 50% eye drops 8*1Also: 50% autologous serum eye drops 8*1clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye | Biological | dry eye patients 1, dry eye patients 2 |
Primary outcome
schirmers test 1 result
Time frame: first month results after two treatment regimes for severe dry eye groupes, 5 minutes tear drop wetness of schirmers paper in milimeters
clinical improvement in schirmer's test 1 result
ocular surface oxford scale
Time frame: first month results after two treatment regimes for severe dry eye groupes, dry eye symptom scale graded 1 to 4
clinical improvement in oxford scale
ocular surface disease index scale (OSDI)
Time frame: first month results after two treatment regimes for severe dry eye groupes, dry eye symptoms graduation prepared with sample questions concluded in 2 digit numbers from 25 to 100,
clinical improvement in OSDI
tear break up time
Time frame: first month results after two treatment regimes for severe dry eye groupes, dry eye quantitave assesment of tear break up time in seconds graded from 0 sec to 10 seconds 10 the best 0 the worst
clinical improvement in tear break up time
fluorescein staining of eye
Time frame: first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4
clinical improvement in fluorescein staining of eye
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Results publication: PubMed 19128374Bradley JC, Bradley RH, McCartney DL, Mannis MJ. Serum growth factor analysis in dry eye syndrome. Clin Exp Ophthalmol. 2008 Nov;36(8):717-20. doi: 10.1111/j.1442-9071.2008.01895.x.
- Results publication: PubMed 17508121Research in dry eye: report of the Research Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):179-93. doi: 10.1016/s1542-0124(12)70086-1.
- Results publication: PubMed 14508260Bron 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.
- Results publication: PubMed 11009316Pflugfelder SC, Solomon A, Stern ME. The diagnosis and management of dry eye: a twenty-five-year review. Cornea. 2000 Sep;19(5):644-9. doi: 10.1097/00003226-200009000-00009.
- Results publication: PubMed 6712760Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.
- Results publication: PubMed 10434857Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjogren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5. doi: 10.1136/bjo.83.4.390.
- Results publication: PubMed 17262232Lopez-Garcia JS, Garcia-Lozano I, Rivas L, Martinez-Garchitorena J. [Use of autologous serum in ophthalmic practice]. Arch Soc Esp Oftalmol. 2007 Jan;82(1):9-20. doi: 10.4321/s0365-66912007000100004. Spanish.
- Results publication: PubMed 26927466Rybickova I, Vesela V, Fales I, Skalicka P, Jirsova K. Apoptosis of conjunctival epithelial cells before and after the application of autologous serum eye drops in severe dry eye disease. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):271-5. doi: 10.5507/bp.2016.001. Epub 2016 Feb 29.
- Results publication: PubMed 9820947Gao J, Schwalb TA, Addeo JV, Ghosn CR, Stern ME. The role of apoptosis in the pathogenesis of canine keratoconjunctivitis sicca: the effect of topical Cyclosporin A therapy. Cornea. 1998 Nov;17(6):654-63. doi: 10.1097/00003226-199811000-00014.
- Results publication: PubMed 19006483Ridder WH 3rd. Ciclosporin use in dry eye disease patients. Expert Opin Pharmacother. 2008 Dec;9(17):3121-8. doi: 10.1517/14656560802500613.
- Results publication: PubMed 20155706Yuksel B, Bozdag B, Acar M, Topaloglu E. Evaluation of the effect of topical cyclosporine A with impression cytology in dry eye patients. Eur J Ophthalmol. 2010 Jul-Aug;20(4):675-9. doi: 10.1177/112067211002000405.
- Results publication: PubMed 12006334Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjogren's Syndrome. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. doi: 10.1136/ard.61.6.554.
- Individual participant dataSharing planned: Yes. study data can be shared
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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.
şeref istek, doctor principal investigator
Department of Ophtalmology, Usak State Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 and AS 50% eye drops 8*1 in people with Dry Eye Syndrome, run by Seref istek.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 12 Sep 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
schirmers test 1 result (time frame: first month results after two treatment regimes for severe dry eye groupes, 5 minutes tear drop wetness of schirmers paper in milimeters). The study lists 5 primary outcomes in all. 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 NCT03666884, which also lists 37 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 Sep 2018.