A Phase 2 interventional study of LME636 ophthalmic solution and LME636 Vehicle in Dry Eye, sponsored by Alcon, a Novartis Company. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-02.
Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when administered topically for up to 42 days, in subjects with severe dry eye disease.
This study is organized into 2 phases. Following a 2-week identification phase, eligible subjects with severe dry eye disease (DED) will be randomized into the treatment phase and will be dispensed study treatment for 10 weeks.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 514 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Alcon left Novartis.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye 3 times a day (TID) for 6 weeks
Biological: LME636 ophthalmic solution
LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
Biological: LME636 Vehicle
Inactive ingredients used as a placebo comparator
Mean Change From Baseline in Global Ocular Discomfort Score at Day 71
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Time frame: Baseline (Day 43), Day 71
Best Corrected Visual Acuity (BCVA)
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.
Time frame: Baseline (Day 43), Day 57, Day 71, Day 85
Intraocular Pressure (IOP)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.
Time frame: Baseline (Day 43), Day 57, Day 71, Day 85
Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit
Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.
Time frame: Baseline (Day 43), Day 57, Day 71, Day 85
Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit
The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.
Time frame: Baseline (Day 43), Day 57, Day 71, Day 85
Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a VAS displayed on a handheld ePRO. Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline.
Time frame: Baseline (Day 43), Day 71
Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. LLOQ is defined as 0.25 ng/mL.
Time frame: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85
Percentage of Subjects With Anti-LME636 Antibodies by Visit
Samples were collected and assessed for anti-LME636 antibodies.
Time frame: Day 15, Day 29, Day 43, Day 57, Day 71, Day 85
Subjects were recruited from 31 investigational sites located in the US.
| Milestone | Vehicle Run-In | LME636 | Vehicle |
|---|---|---|---|
| Started | 213 | 0 | 0 |
| Completed | 134 | 0 | 0 |
| Not completed | 79 | 0 | 0 |
| Milestone | Vehicle Run-In | LME636 | Vehicle |
|---|---|---|---|
| Started | 0 | 69 | 65 |
| Completed | 0 | 67 | 64 |
| Not completed | 0 | 2 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
| units on a scale | LME636 | Vehicle |
|---|---|---|
| Mean Change From Baseline in Global Ocular Discomfort Score at Day 71 | -7.9 ± 1.45 | -3.6 ± 1.49 |
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.
| letters | LME636 | Vehicle |
|---|---|---|
| Baseline (Day 43) | 80.6 ± 6.44 | 81.5 ± 5.72 |
| Day 57 | 80.5 ± 6.82 | 81.6 ± 5.48 |
| Day 71 | 81.6 ± 5.56 | 81.9 ± 5.89 |
| Day 85 | 81.0 ± 5.73 | 81.6 ± 6.17 |
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.
| mmHg | LME636 | Vehicle |
|---|---|---|
| Baseline (Day 43) | 14.8 ± 2.71 | 14.3 ± 2.63 |
| Day 57 | 14.6 ± 2.72 | 14.1 ± 2.92 |
| Day 71 | 14.0 ± 3.06 | 14.1 ± 2.70 |
| Day 85 | 14.4 ± 2.68 | 14.6 ± 2.58 |
Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.
| percentage of subjects | LME636 | Vehicle |
|---|---|---|
| Cornea | 0.0 | 0.0 |
| Lens | 0.0 | 0.0 |
| Iris | 0.0 | 0.0 |
| Anterior Chamber | 0.0 | 0.0 |
The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.
| percentage of subjects | LME636 | Vehicle |
|---|---|---|
| Vitreous | 1.4 | 1.5 |
| Retina | 1.4 | 0.0 |
| Macula | 0.0 | 0.0 |
| Choroid | 0.0 | 0.0 |
| Optic Nerve | 0.0 | 0.0 |
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a VAS displayed on a handheld ePRO. Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline.
| percentage of subjects | LME636 | Vehicle |
|---|---|---|
| Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71 | 17.9 | 4.7 |
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. LLOQ is defined as 0.25 ng/mL.
| percentage of subjects | LME636 |
|---|---|
| Day 15 | 100.0 |
| Day 29 | 100.0 |
| Day 43 (prior to administration of first dose) | 98.5 |
| Day 57 | 82.1 |
| Day 71 | 71.9 |
| Day 85 (last day of dosing) | 67.9 |
Samples were collected and assessed for anti-LME636 antibodies.
| percentage of subjects | LME636 | Vehicle | Run-In Only |
|---|---|---|---|
| Day 15 | 33.3 | 40.0 | 26.9 |
| Day 29 | 37.3 | 37.7 | 27.0 |
| Day 43 (prior to administration of first dose) | 31.9 | 34.9 | 27.0 |
| Day 57 (Treatment Day 15) | 45.6 | 41.1 | — |
| Day 71 | 79.3 | 41.7 | — |
| Day 85 (last day of dosing) | 86.8 | 40.4 | — |
Collected over Adverse events (AEs) were collected from time of informed consent for the duration of a subject's participation in the study (up to 85 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Run-In | 0/213 (0%) | 1/213 (0.5%) | 0/213 (0%) |
| LME636 | 0/69 (0%) | 0/69 (0%) | 0/69 (0%) |
| Vehicle | 0/65 (0%) | 1/65 (1.5%) | 0/65 (0%) |
| Event | Vehicle Run-In | LME636 | Vehicle |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/213 | 0/69 | 1/65 |
| Extradural abscessInfections and infestations | 1/213 | 0/69 | 0/65 |
This analysis population includes all randomized and treated subjects.
| Age, Continuous(years) | LME636 | Vehicle | Total |
|---|---|---|---|
| Mean | 61.7 ± 13.05 | 58.8 ± 14.48 | 60.3 ± 13.78 |
| Sex: Female, Male(Participants) | LME636 | Vehicle | Total |
|---|---|---|---|
| Female | 61 | 54 | 115 |
| Male | 8 | 11 | 19 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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