Trial Outcomes & Findings for Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis (NCT NCT01569191)
NCT ID: NCT01569191
Last Updated: 2018-02-05
Results Overview
Short questionnaire Ocular allergy symptomology was also measured using the eye symptom section from the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) on a 0 to 6 scale, with the summed score for itching, watering, swelling and soreness resulting in a summed score between 0 and 24. A higher score indicates a worse outcome (more severe symptoms)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
1 hour
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
No Treatment/Artificial Tear / Cold Compress / Pharmaceutical
Exposure to grass pollen only
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear
Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist
|
No Treatment / Artificial Tear / Cold Compress
Exposure to grass pollen only
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear
Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
No Treatment / Artificial Tear / Cold Compress / Pharmaceutica
n=7 Participants
Exposure to grass pollen only
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear
Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis
ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen
|
No Treatment / Artificial Tear / Cold Compress
n=11 Participants
Exposure to grass pollen only
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear
Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
29.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourShort questionnaire Ocular allergy symptomology was also measured using the eye symptom section from the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) on a 0 to 6 scale, with the summed score for itching, watering, swelling and soreness resulting in a summed score between 0 and 24. A higher score indicates a worse outcome (more severe symptoms)
Outcome measures
| Measure |
No Treatment
n=18 Participants
Exposure to grass pollen only
|
Artificial Tear Supplement
n=18 Participants
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006
Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)
|
Cold Compress
n=18 Participants
Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
|
Anti-allergic Medication
n=11 Participants
ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis
ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen
|
|---|---|---|---|---|
|
Symptoms
|
15.3 Units on a scale
Standard Deviation 1.8
|
11.3 Units on a scale
Standard Deviation 1.2
|
13.3 Units on a scale
Standard Deviation 1.1
|
9.8 Units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 1 hourBulbar and limbal redness will be observed with a slit lamp biomicroscope and graded using a validated scale • The 'Efron' grading scale consists of 5 pictures of eyes of increasing severity of blood vessels over the white of the eye, with the clinician selecting the image closest to what they observe on the patient (0 indicating a white eye and 4 a very irritated eye). There are no subscales
Outcome measures
| Measure |
No Treatment
n=18 Participants
Exposure to grass pollen only
|
Artificial Tear Supplement
n=18 Participants
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006
Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)
|
Cold Compress
n=18 Participants
Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
|
Anti-allergic Medication
n=11 Participants
ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis
ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen
|
|---|---|---|---|---|
|
Ocular Redness
|
2.15 units on a scale
Standard Deviation 0.40
|
1.79 units on a scale
Standard Deviation 0.40
|
1.61 units on a scale
Standard Deviation 0.32
|
1.78 units on a scale
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: 1 hourOcular surface temperature will be measured with an infra-red camera
Outcome measures
| Measure |
No Treatment
n=18 Participants
Exposure to grass pollen only
|
Artificial Tear Supplement
n=18 Participants
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006
Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose)
|
Cold Compress
n=18 Participants
Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
|
Anti-allergic Medication
n=11 Participants
ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis
ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen
|
|---|---|---|---|---|
|
Ocular Temperature
|
35.88 degrees centrigrade
Standard Deviation 0.75
|
35.91 degrees centrigrade
Standard Deviation 0.96
|
35.41 degrees centrigrade
Standard Deviation 0.88
|
34.56 degrees centrigrade
Standard Deviation 0.85
|
Adverse Events
No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artificial Tear Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cold Compress
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anti-allergic Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place