Trial Outcomes & Findings for Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC) (NCT NCT00328653)
NCT ID: NCT00328653
Last Updated: 2021-12-14
Results Overview
The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986): 1. = Overall worsening of the subjective findings. 2. = No change in the symptoms. 3. = Slight improvement with the child still unable to participate in all normal daily activities. 4. = Marked improvement despite temporary mild itching or mucus discharge. 5. = Completely free of all symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
118 participants
Primary outcome timeframe
Week 4
Results posted on
2021-12-14
Participant Flow
Participant milestones
| Measure |
Vehicle
Vehicle administered four times daily
|
NOVA22007 0.05%
Cyclosporine NOVA22007 0.05% four times daily
|
NOVA22007 0.1%
Cyclosporine NOVA22007 0.1% four times daily
|
|---|---|---|---|
|
Period I
STARTED
|
40
|
39
|
39
|
|
Period I
COMPLETED
|
36
|
39
|
36
|
|
Period I
NOT COMPLETED
|
4
|
0
|
3
|
|
Period II
STARTED
|
0
|
58
|
53
|
|
Period II
COMPLETED
|
0
|
50
|
49
|
|
Period II
NOT COMPLETED
|
0
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)
Baseline characteristics by cohort
| Measure |
NOVA22007 0.05%
n=39 Participants
Cyclosporine NOVA22007 0.05% four times daily
|
NOVA22007 0.1%
n=39 Participants
Cyclosporine NOVA22007 0.1% four times daily
|
Vehicle
n=40 Participants
Vehicle administered four times daily
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
8.5 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: FAS population
The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986): 1. = Overall worsening of the subjective findings. 2. = No change in the symptoms. 3. = Slight improvement with the child still unable to participate in all normal daily activities. 4. = Marked improvement despite temporary mild itching or mucus discharge. 5. = Completely free of all symptoms.
Outcome measures
| Measure |
Vehicle
n=40 Participants
Vehicle administered four times daily
|
NOVA22007 0.05%
n=39 Participants
Cyclosporine NOVA22007 0.05% four times daily
|
NOVA22007 0.1%
n=39 Participants
Cyclosporine NOVA22007 0.1% four times daily
|
|---|---|---|---|
|
Overall Rating of Subjective Symptoms of VKC in Period I
1- Overall worsening of the
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Overall Rating of Subjective Symptoms of VKC in Period I
2- No change in the symptoms
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Overall Rating of Subjective Symptoms of VKC in Period I
3- Slight improvement
|
10 Participants
|
15 Participants
|
11 Participants
|
|
Overall Rating of Subjective Symptoms of VKC in Period I
4- Marked improvement
|
15 Participants
|
19 Participants
|
20 Participants
|
|
Overall Rating of Subjective Symptoms of VKC in Period I
5- Completely free of all symptoms
|
3 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 4Overall rating of objective signs was to be assessed under the slit lamp by the Investigator and recorded on a five-point scale based on BenEzra trial (BenEzra 1986): 1. Intense congestion of conjunctival vessels, perilimbal injection, or corneal involvement with the papillary proliferations more extensive or similar to the situation recorded before treatment in at least one of the eyes. 2. The overall condition was assessed as better than before treatment in both eyes. 3. Total re-epithelialisation of the cornea although slight conjunctival and perilimbal hyperaemia and papillary proliferations remains in both eyes. 4. Only slight conjunctival hyperaemia without perilimbal injection or papillary proliferations in at least one eye 5. Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection.
Outcome measures
| Measure |
Vehicle
n=40 Participants
Vehicle administered four times daily
|
NOVA22007 0.05%
n=39 Participants
Cyclosporine NOVA22007 0.05% four times daily
|
NOVA22007 0.1%
n=39 Participants
Cyclosporine NOVA22007 0.1% four times daily
|
|---|---|---|---|
|
Overall Rating of Objective Symptoms of VKC in Period I
1.Intense congestion of conjunctival vessels, perilimbal injection, or corneal involvement.
|
18 Participants
|
8 Participants
|
7 Participants
|
|
Overall Rating of Objective Symptoms of VKC in Period I
2.The overall condition was assessed as better than before treatment in both eyes.
|
13 Participants
|
17 Participants
|
16 Participants
|
|
Overall Rating of Objective Symptoms of VKC in Period I
3.Total re-epithelialisation of the cornea
|
4 Participants
|
7 Participants
|
12 Participants
|
|
Overall Rating of Objective Symptoms of VKC in Period I
4.Only slight conjunctival hyperaemia in at least one eye
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Overall Rating of Objective Symptoms of VKC in Period I
4.Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection.
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Month1Population: The number of participants is reduced due to missing data.
Outcome measures
| Measure |
Vehicle
n=40 Participants
Vehicle administered four times daily
|
NOVA22007 0.05%
n=39 Participants
Cyclosporine NOVA22007 0.05% four times daily
|
NOVA22007 0.1%
n=39 Participants
Cyclosporine NOVA22007 0.1% four times daily
|
|---|---|---|---|
|
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Week1- Baseline
|
-0.5 instillations
Standard Deviation 1.5
|
0.1 instillations
Standard Deviation 2.2
|
-0.1 instillations
Standard Deviation 1.3
|
|
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Week2- Baseline
|
-0.2 instillations
Standard Deviation 0.9
|
-0.4 instillations
Standard Deviation 1.4
|
-0.2 instillations
Standard Deviation 1.5
|
|
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Month1-Baseline
|
-0.4 instillations
Standard Deviation 1.9
|
-0.5 instillations
Standard Deviation 1.5
|
0.0 instillations
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Up to Month1Population: The number of participants is reduced due to missing data.
Are the tested eye drops (other than concomitant tear substitute ) comfortable?
Outcome measures
| Measure |
Vehicle
n=40 Participants
Vehicle administered four times daily
|
NOVA22007 0.05%
n=39 Participants
Cyclosporine NOVA22007 0.05% four times daily
|
NOVA22007 0.1%
n=39 Participants
Cyclosporine NOVA22007 0.1% four times daily
|
|---|---|---|---|
|
Ocular Tolerance in Period I
Week1 · Yes
|
35 Participants
|
24 Participants
|
34 Participants
|
|
Ocular Tolerance in Period I
Week1 · No
|
3 Participants
|
11 Participants
|
4 Participants
|
|
Ocular Tolerance in Period I
Week2 · No
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Ocular Tolerance in Period I
Week2 · Yes
|
34 Participants
|
33 Participants
|
31 Participants
|
|
Ocular Tolerance in Period I
Month1 · No
|
2 Participants
|
8 Participants
|
7 Participants
|
|
Ocular Tolerance in Period I
Month1 · Yes
|
34 Participants
|
31 Participants
|
29 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Period I- NOVA22007 0.05%
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Period I-NOVA22007 0.1%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Period II- NOVA22007 0.05%
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Period II-NOVA22007 0.1%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
|
Period I- NOVA22007 0.05%
n=39 participants at risk
Low Dose Regimen
|
Period I-NOVA22007 0.1%
n=39 participants at risk
High Dose Regimen
|
Period II- NOVA22007 0.05%
n=58 participants at risk
|
Period II-NOVA22007 0.1%
n=53 participants at risk
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
|
Period I- NOVA22007 0.05%
n=39 participants at risk
Low Dose Regimen
|
Period I-NOVA22007 0.1%
n=39 participants at risk
High Dose Regimen
|
Period II- NOVA22007 0.05%
n=58 participants at risk
|
Period II-NOVA22007 0.1%
n=53 participants at risk
|
|---|---|---|---|---|---|
|
Eye disorders
Allergic keratitis
|
22.5%
9/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
7.7%
3/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
20.5%
8/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Visual acuity reduced
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
7.7%
3/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
5.2%
3/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Ocular hyperaemia
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
5.1%
2/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
5.1%
2/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Blepharitis
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Corneal Epithelium disorder
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Keratitis
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Instillation site pain
|
5.0%
2/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Instillation site pruritus
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
12.8%
5/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
10.3%
4/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
5.2%
3/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Drug intolerance
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
5.1%
2/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
6.9%
4/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Hyperthermia
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Instillation site lacrimation
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Pain
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Infections and infestations
Varicella
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Injury, poisoning and procedural complications
Face injury
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
2.6%
1/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Eye disorders
Corneal Ulcer
|
7.5%
3/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.7%
1/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
1.9%
1/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
General disorders
Instillation Site Irritation
|
0.00%
0/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
10.3%
4/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
5.1%
2/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
3.4%
2/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
7.5%
4/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.5%
1/40 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/39 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/58 • From the time the patient gave informed consent until the last trial visit at month 4.
|
0.00%
0/53 • From the time the patient gave informed consent until the last trial visit at month 4.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place