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This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-LASIK 0.3% hypromellose | Experimental |
| |
| Post-LASIK 0.3% hypromellose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-LASIK 0.3% hypromellose | Drug | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Comfort Level From Baseline to End of Study | Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement. | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Breakup Time From Baseline to End of Study | The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis India Ltd. | Novartis India Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Delhi | 110088 | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-LASIK 0.3% Hypromellose | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery. |
| FG001 | Post-LASIK 0.3% Hypromellose | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-LASIK 0.3% Hypromellose | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery. |
| BG001 | Post-LASIK 0.3% Hypromellose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Comfort Level From Baseline to End of Study | Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement. | Intent-to-Treat population: All patients in the study who received study treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-LASIK 0.3% Hypromellose | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065347 | Hypromellose Derivatives |
| ID | Term |
|---|---|
| D002482 | Cellulose |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Post-LASIK 0.3% hypromellose | Drug | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery. |
|
| Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery |
| Results of Schirmer's Test From Baseline to End of Study | Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement. | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery |
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Post-LASIK 0.3% Hypromellose |
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery. |
|
|
| Secondary | Tear Breakup Time From Baseline to End of Study | The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement. | Intent-to-Treat population: All patients in the study who received study treatment. | Posted | Mean | Standard Deviation | Seconds | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery |
|
|
|
| Secondary | Results of Schirmer's Test From Baseline to End of Study | Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement. | Intent-to-Treat population: All patients in the study who received study treatment. | Posted | Mean | Standard Deviation | mm | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Post-LASIK 0.3% Hypromellose | Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery. | 0 | 90 | 0 | 90 |
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Day 30 |
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| Left eye: Day 30 |
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| Right eye: Post-LASIK Day 1 |
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| Right eye: Day 7 |
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| Right eye: Day 30 |
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