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Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium

Primary Purpose

Dry Eye Syndromes, Pterygium

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dipyridamole

Placebo

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Dipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year

Fluorescein in Active Vehicle 1 drop three times a day for 1 year

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02782260

First Posted

May 10, 2016

Last Updated

May 24, 2016

Sponsor

Ariel University

1. Study Identification

Unique Protocol Identification Number

NCT02782260

Brief Title

Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ariel University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes, Pterygium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

Dipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Fluorescein in Active Vehicle 1 drop three times a day for 1 year

Intervention Type

Drug

Intervention Name(s)

Dipyridamole

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Assess the changes in dry eye parameters via a change in tear secretion rate

Description

Time Frame

6 months

Title

Assess the changes in dry eye parameters via reduction in dry eye symptomology.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium

Description

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).

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium

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