Dry Eye SyndromesPhase 2NCT02782260
Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium
A Phase 2 study testing Dipyridamole in people with Dry Eye Syndromes and Pterygium, run by Ariel University.
Trial summary
Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Pterygium
- What is being tested?
- Dipyridamole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jan 2018
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- Ineligible or refused surgical excision, or had recurrence of pterygium following surgical excision
- Able to follow the study instructions, including application of the study product
- Agreement not to change the type of lubricating eye drops used (if any) during their participation in the study.
- Assessed as having at least pterygium stage 0-1 (pinguecula) based on Johnston, Williams \& Sheppard's classification for pterygium
- Concomitant dry eye symptoms, as determined by one or more of the following Subject interview (modified Ocular Surface Disease Index test), Tearing, Itch / foreign body sensation, Positive Fluorescein test, Positive TBUT test, Positive Tear meniscus test
Who cannot join
- Inability to provide informed consent
- Dry eye due to other factors
- Known lacrimal obstruction
- Contact lens wearers
- Non-corrected refraction
- Allergy or sensitivity to dipyridamole or excipients
Show all 14Show fewer
- Use of dipyridamole in the last 6 months
- Other eye conditions (i.e. active ocular infection, herpes keratitis in last 6 months, corneal disorder abnormality excluding pterygium, history of ocular acne rosacea, blepharitis) which would impact results
- Diagnosis of ALS (Amyotrophic lateral sclerosis)
- Existing conditions which are contraindicated or precaution in use of dipyridamole or excipients
- Use of eye drops (other than ocular lubricants)
- Pregnant or breastfeeding
- Inability to apply the medical product or follow the study procedures
- Anything that the PI thinks would impact the trial
About this study
Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.
- Conditions
- Dry Eye Syndromes, Pterygium
- Being tested
- Dipyridamole, Placebo
- Medical subject headings
- Dry Eye Syndromes, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DipyridamoleDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Dipyridamole eye drops 8.48 mg in 100ml
1 drop three times a day for 1 year Receives: Drug: Dipyridamole |
| Placebo | Placebo comparator | Fluorescein in Active Vehicle
1 drop three times a day for 1 year Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the changes in dry eye parameters via a change in tear secretion rate
Change in the tear secretion rate will be defined by successful change in parameters of ONE of the following testing methods compared to baseline:
- Fluorescein - Improvement of one of the quadrants sufficient to change the severity rating
- TBUT (Tear Breakup time) - Decreased by at least 1 second
- Tear meniscus test - Increase of at least 0.2mm
Measured: 6 months
Assess the changes in dry eye parameters via reduction in dry eye symptomology.
Reduction in dry eye symptomology will be defined as ONE of the following relative to baseline, determined by subject feedback
- An improvement in questionnaire scores
- Specified improvement in blurred vision grading
- Specified improvement in tearing grading
- Specified improvement in itch / foreign body (grittiness) sensation grading.
Measured: 6 months
Secondary outcomes (1)
A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium
Minimum significant reversion will be defined as a decrease in vascularisation, or a measurable decrease from baseline of OCT (Ocular Coherence Tomography) measured parameters (height or width).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lily Karmona, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782260
- Sponsor's protocol ID
- 0064-16-WOMC
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium
- ClinicalTrials.gov ID
- NCT02782260
- Acronym / sponsor ID
- 0064-16-WOMC
- Conditions
- Dry Eye Syndromes, Pterygium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 May 2016 (estimated)
- 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.
Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: DipyridamoleDipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year |
| Placebo | Placebo comparator | Drug: PlaceboFluorescein in Active Vehicle 1 drop three times a day for 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide informed consent.
- Ineligible or refused surgical excision, or had recurrence of pterygium following surgical excision
- Able to follow the study instructions, including application of the study product
- Agreement not to change the type of lubricating eye drops used (if any) during their participation in the study.
- Assessed as having at least pterygium stage 0-1 (pinguecula) based on Johnston, Williams \& Sheppard's classification for pterygium
Key exclusion criteria (14 listed)
- Inability to provide informed consent
- Dry eye due to other factors
- Known lacrimal obstruction
- Contact lens wearers
- Non-corrected refraction
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 |
|---|---|---|
| Dipyridamole | Drug | Active |
| Placebo | Drug | Placebo |
Primary outcome
Assess the changes in dry eye parameters via a change in tear secretion rate
Time frame: 6 months
Change in the tear secretion rate will be defined by successful change in parameters of ONE of the following testing methods compared to baseline: 1. Fluorescein - Improvement of one of the quadrants sufficient to change the severity rating 2. TBUT (Tear Breakup time) - Decreased by at least 1 second 3. Tear meniscus test - Increase of at least 0.2mm
Assess the changes in dry eye parameters via reduction in dry eye symptomology.
Time frame: 6 months
Reduction in dry eye symptomology will be defined as ONE of the following relative to baseline, determined by subject feedback * An improvement in questionnaire scores * Specified improvement in blurred vision grading * Specified improvement in tearing grading * Specified improvement in itch / foreign body (grittiness) sensation grading.
1 secondary outcome
A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dipyridamole in people with Dry Eye Syndromes and Pterygium, run by Ariel University.
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 6 inclusion and 14 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 25 May 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Assess the changes in dry eye parameters via a change in tear secretion rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2016.