Dry Eye
Conditions
Keywords
Post LASIK dry eye, Pre LASIK dry eye, Hypromellose
Brief summary
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).
Interventions
DRUGPre-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.
DRUGPost-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.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Age 21 - 35 * Both sexes * Seeking LASIK surgery at the Refractive Surgery Centre * Meeting all established criteria for appropriateness for LASIK established by the treating center
Exclusion criteria
* Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant * Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus * Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment * Anticipated refusal or inability to undergo planned post-operative visits or assessment * Failure to meet all established criteria for appropriateness for LASIK
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort Level From Baseline to End of Study | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Breakup Time From Baseline to End of Study | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery | 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. |
| Results of Schirmer's Test From Baseline to End of Study | Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery | 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. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| 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. | 90 |
| Total | 162 |
Baseline characteristics
| Characteristic | Pre-LASIK 0.3% Hypromellose | Post-LASIK 0.3% Hypromellose | Total |
|---|---|---|---|
| Age, Continuous | 26.24 Years STANDARD_DEVIATION 4.81 | 25.99 Years STANDARD_DEVIATION 5.06 | 26.10 Years STANDARD_DEVIATION 4.93 |
| Sex: Female, Male Female | 50 Participants | 66 Participants | 116 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 72 | 0 / 90 |
| serious Total, serious adverse events | 0 / 72 | 0 / 90 |
Outcome results
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.
Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Population: Intent-to-Treat population: All patients in the study who received study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Burning in eyes: Post-LASIK Day 1 | 0.68 Units on a scale | Standard Deviation 1.18 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Burning in eyes: Day 7 | 0.24 Units on a scale | Standard Deviation 0.52 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Burning in eyes: Day 30 | 0.08 Units on a scale | Standard Deviation 0.33 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Foreign body sensation: Post-LASIK Day 1 | 0.94 Units on a scale | Standard Deviation 1.47 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Foreign body sensation: Day 7 | 0.26 Units on a scale | Standard Deviation 0.56 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Foreign body sensation: Day 30 | 0.05 Units on a scale | Standard Deviation 0.29 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Itching: Post-LASIK Day 1 | 0.35 Units on a scale | Standard Deviation 0.77 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Itching: Day 7 | 0.16 Units on a scale | Standard Deviation 0.48 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Itching: Day 30 | 0.05 Units on a scale | Standard Deviation 0.22 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Watering of eyes: Post-LASIK Day 1 | 0.71 Units on a scale | Standard Deviation 0.94 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Watering of eyes: Day 7 | 0.22 Units on a scale | Standard Deviation 0.49 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Watering of eyes: Day 30 | 0.10 Units on a scale | Standard Deviation 0.3 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Dryness of eyes: Post-LASIK Day 1 | 0.82 Units on a scale | Standard Deviation 1.18 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Dryness of eyes: Day 7 | 0.41 Units on a scale | Standard Deviation 0.72 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Dryness of eyes: Day 30 | 0.25 Units on a scale | Standard Deviation 0.6 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Photophobia: Post-LASIK Day 1 | 0.22 Units on a scale | Standard Deviation 0.54 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Photophobia: Day 7 | 0.09 Units on a scale | Standard Deviation 0.33 |
| Pre-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Photophobia: Day 30 | 0.08 Units on a scale | Standard Deviation 0.33 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Dryness of eyes: Day 7 | 0.72 Units on a scale | Standard Deviation 0.98 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Burning in eyes: Post-LASIK Day 1 | 0.84 Units on a scale | Standard Deviation 1.16 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Watering of eyes: Post-LASIK Day 1 | 0.71 Units on a scale | Standard Deviation 0.96 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Burning in eyes: Day 7 | 0.31 Units on a scale | Standard Deviation 0.54 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Photophobia: Day 30 | 0.07 Units on a scale | Standard Deviation 0.26 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Burning in eyes: Day 30 | 0.07 Units on a scale | Standard Deviation 0.26 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Watering of eyes: Day 7 | 0.25 Units on a scale | Standard Deviation 0.49 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Foreign body sensation: Post-LASIK Day 1 | 1.09 Units on a scale | Standard Deviation 1.41 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Dryness of eyes: Day 30 | 0.49 Units on a scale | Standard Deviation 0.84 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Foreign body sensation: Day 7 | 0.27 Units on a scale | Standard Deviation 0.55 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Watering of eyes: Day 30 | 0.09 Units on a scale | Standard Deviation 0.29 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Foreign body sensation: Day 30 | 0.09 Units on a scale | Standard Deviation 0.33 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Photophobia: Day 7 | 0.09 Units on a scale | Standard Deviation 0.37 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Itching: Post-LASIK Day 1 | 0.71 Units on a scale | Standard Deviation 1.21 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Dryness of eyes: Post-LASIK Day 1 | 1.28 Units on a scale | Standard Deviation 1.71 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Itching: Day 7 | 0.32 Units on a scale | Standard Deviation 0.68 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Photophobia: Post-LASIK Day 1 | 0.41 Units on a scale | Standard Deviation 0.9 |
| Post-LASIK 0.3% Hypromellose | Ocular Comfort Level From Baseline to End of Study | Itching: Day 30 | 0.13 Units on a scale | Standard Deviation 0.42 |
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.
Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Population: Intent-to-Treat population: All patients in the study who received study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pre-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Left eye: Day 7 | 17.68 mm | Standard Deviation 9.93 |
| Pre-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Right eye: Post-LASIK Day 1 | 22.65 mm | Standard Deviation 7.1 |
| Pre-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Left eye: Post-LASIK Day 1 | 19.64 mm | Standard Deviation 8.5 |
| Pre-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Left eye: Day 30 | 21.70 mm | Standard Deviation 13.01 |
| Pre-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Right eye: Day 30 | 22.89 mm | Standard Deviation 2.47 |
| Pre-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Right eye: Day 7 | 22.78 mm | Standard Deviation 0.49 |
| Post-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Right eye: Day 30 | 18.35 mm | Standard Deviation 3.83 |
| Post-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Left eye: Post-LASIK Day 1 | 17.21 mm | Standard Deviation 7.1 |
| Post-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Left eye: Day 7 | 17.93 mm | Standard Deviation 5.43 |
| Post-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Left eye: Day 30 | 18.77 mm | Standard Deviation 7.11 |
| Post-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Right eye: Post-LASIK Day 1 | 13.70 mm | Standard Deviation 2.91 |
| Post-LASIK 0.3% Hypromellose | Results of Schirmer's Test From Baseline to End of Study | Right eye: Day 7 | 15.25 mm | Standard Deviation 0.49 |
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.
Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Population: Intent-to-Treat population: All patients in the study who received study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pre-LASIK 0.3% Hypromellose | Tear Breakup Time From Baseline to End of Study | Post-LASIK Day 1 | 14.60 Seconds | Standard Deviation 6.06 |
| Pre-LASIK 0.3% Hypromellose | Tear Breakup Time From Baseline to End of Study | Day 7 | 13.47 Seconds | Standard Deviation 6.22 |
| Pre-LASIK 0.3% Hypromellose | Tear Breakup Time From Baseline to End of Study | Day 30 | 13.63 Seconds | Standard Deviation 5.36 |
| Post-LASIK 0.3% Hypromellose | Tear Breakup Time From Baseline to End of Study | Post-LASIK Day 1 | 12.47 Seconds | Standard Deviation 6.2 |
| Post-LASIK 0.3% Hypromellose | Tear Breakup Time From Baseline to End of Study | Day 7 | 10.84 Seconds | Standard Deviation 3.58 |
| Post-LASIK 0.3% Hypromellose | Tear Breakup Time From Baseline to End of Study | Day 30 | 12.70 Seconds | Standard Deviation 5.38 |