Trial Outcomes & Findings for A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction (NCT NCT01633788)
NCT ID: NCT01633788
Last Updated: 2017-09-08
Results Overview
Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
232 participants
Primary outcome timeframe
Month 6
Results posted on
2017-09-08
Participant Flow
Patients from one site were excluded from the modified intent-to-treat analysis population due to compliance issues. Patients from this site who received study treatment were included in the safety population and are reflected in the participant flow.
Participant milestones
| Measure |
AGN-195263 0.1%
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
58
|
59
|
58
|
|
Overall Study
COMPLETED
|
50
|
50
|
49
|
45
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
10
|
13
|
Reasons for withdrawal
| Measure |
AGN-195263 0.1%
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
0
|
|
Overall Study
Personal Reasons
|
3
|
1
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
|
Overall Study
Other Reasons
|
0
|
2
|
3
|
7
|
Baseline Characteristics
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
AGN-195263 0.1%
n=57 Participants
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
n=58 Participants
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
n=59 Participants
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
n=58 Participants
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
40 year to less than 55 years
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
73 participants
n=21 Participants
|
|
Age, Customized
55 years to 65 years
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
19 participants
n=5 Participants
|
18 participants
n=4 Participants
|
87 participants
n=21 Participants
|
|
Age, Customized
over 65 years
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
21 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
156 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point
Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
Outcome measures
| Measure |
AGN-195263 0.1%
n=54 Participants
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
n=56 Participants
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
n=53 Participants
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
n=49 Participants
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
Percentage of Meibum Quality Responders in the Study Eye
|
46.3 Percentage of Patients
|
33.9 Percentage of Patients
|
32.1 Percentage of Patients
|
42.9 Percentage of Patients
|
SECONDARY outcome
Timeframe: Month 6Population: Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point
The MQS is assessed based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.
Outcome measures
| Measure |
AGN-195263 0.1%
n=54 Participants
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
n=56 Participants
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
n=53 Participants
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
n=49 Participants
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
|
20.4 Percentage of Patients
|
23.2 Percentage of Patients
|
15.1 Percentage of Patients
|
22.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Month 6Population: Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point
Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.
Outcome measures
| Measure |
AGN-195263 0.1%
n=55 Participants
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
n=56 Participants
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
n=54 Participants
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
n=51 Participants
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
Percentage of Complete Overall Ocular Discomfort Responders
|
20.0 Percentage of Patients
|
19.6 Percentage of Patients
|
14.8 Percentage of Patients
|
9.8 Percentage of Patients
|
Adverse Events
AGN-195263 0.1%
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
AGN-195263 0.03%
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
AGN-195263 0.01%
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-195263 Vehicle
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AGN-195263 0.1%
n=57 participants at risk
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
n=58 participants at risk
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
n=59 participants at risk
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
n=58 participants at risk
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
General disorders
Gait disturbance
|
1.8%
1/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
Other adverse events
| Measure |
AGN-195263 0.1%
n=57 participants at risk
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
|
AGN-195263 0.03%
n=58 participants at risk
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
|
AGN-195263 0.01%
n=59 participants at risk
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
|
AGN-195263 Vehicle
n=58 participants at risk
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|---|---|
|
Eye disorders
Eye pruritus
|
5.3%
3/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
3.4%
2/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
3.4%
2/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Eye disorders
Foreign body sensation in eyes
|
5.3%
3/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Eye disorders
Lacrimation increased
|
5.3%
3/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
6.9%
4/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/57
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
6.9%
4/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/59
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
1.7%
1/58
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
|
Investigations
Prostatic specific antigen increased
|
5.6%
1/18
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/19
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
0.00%
0/20
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
10.5%
2/19
The Safety Population is used to assess adverse events and serious adverse events and consists of all patients who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER