Allergic Conjunctivitis
Conditions
Keywords
Allergic conjunctivitis, Red eyes, Eyelid swelling, Ragweed, Allergies, Itchy eyes, Ocular redness, Chemosis, Tearing, Watery eyes
Brief summary
The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.
Detailed description
Eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects received study product and began dosing for up to 9 days. The final visit was the final day of dosing. Participation in this study lasted up to 68 days.
Interventions
DRUGAL-53817 Ophthalmic Solution, 0.1%
DRUGAL-78843 Ophthalmic Solution, 0.03%
DRUGAL-53817 Vehicle
Inactive ingredients used for masking purposes
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent * Use of condom by sexually active males for the entire duration of the study. * Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method). * Able and willing to comply with study protocol and follow protocol instructions. * Able to avoid any of the topical ocular or systemic excluded medications during the entire study period. * At least 1 year subject-reported or physician-diagnosed history (prior to Screen Visit) of allergic conjunctivitis during the ragweed season. * Positive skin prick test for short ragweed allergen within 12 months prior to Screen Visit. * Significant staff-assessed ocular redness in at least one region in each eye within the 3 hour period of allergen exposure in the EEC (Screen Visits). * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product. * Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye. * History of any ocular infection, physician or subject diagnosed, within 30 days prior to Screen Visit. * Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension. * Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes. * Corneal conditions affecting the corneal structure. * Unwilling to discontinue contact lens wear during the study period. * Any ocular surgery including ocular laser procedures within 1 year prior to Screen Visit. * Current or recent (\<6 months prior to Screen Visit) history of severe, unstable, or uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal, psychological, respiratory, gastrointestinal and/or immunological disease or evidence of other diseases based upon a review of medical history and/or physical examination that, in the opinion of the Investigator, would preclude safe subject participation in the study. * Receiving treatment for anxiety and/or depression at the Screen Visit; any history of suicide attempt. * Participation in any investigational study within 30 days of Screen Visit or concomitantly with this study. * Known contraindications or hypersensitivities to any of the study medications or their components * Confirmed (by physician or optometrist) diagnosis of dry eye. * History of sensitivity or adverse reaction to steroids. * Known allergic reaction that is unresponsive to corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDS). * Physician diagnosed asthma (except inactive childhood asthma and exercise-induced asthma). * Evidence of active inflammation in the eye as determined by the dilated fundus examination conducted at Screen C Visit. * Any corneal swelling or haze as determined by the slitlamp examination conducted at Screen C Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7 | Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7 | Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the US.
Pre-assignment details
Of the 224 enrolled, 60 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects. Note: 2 randomized subjects were exited prior to treatment.
Participants by arm
| Arm | Count |
|---|---|
| AL-78843 One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) | 41 |
| AL-53817 One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) | 41 |
| Maxidex One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) | 40 |
| Vehicle One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) | 40 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Randomization error (prior to treatment) | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | AL-78843 | AL-53817 | Maxidex | Vehicle | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 13.4 | 46.4 years STANDARD_DEVIATION 13.3 | 40.9 years STANDARD_DEVIATION 13.1 | 46.0 years STANDARD_DEVIATION 12.6 | 44.0 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 24 Participants | 24 Participants | 88 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 16 Participants | 16 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 224 | 0 / 41 | 0 / 41 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 224 | 0 / 41 | 0 / 41 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.
Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7
Population: This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AL-78843 | Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -2.8 hours x units on a scale | Standard Error 0.68 |
| AL-53817 | Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -4.7 hours x units on a scale | Standard Error 0.68 |
| Maxidex | Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -8.1 hours x units on a scale | Standard Error 0.69 |
| Vehicle | Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -4.5 hours x units on a scale | Standard Error 0.7 |
Secondary
Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\].
Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7
Population: This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AL-78843 | Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -7.8 hours x units on a scale | Standard Error 1 |
| AL-53817 | Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -8.8 hours x units on a scale | Standard Error 1 |
| Maxidex | Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -10.7 hours x units on a scale | Standard Error 1.01 |
| Vehicle | Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 | -8.5 hours x units on a scale | Standard Error 1.04 |