Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00909324
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 33.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Pre-LASIK 0.3% hypromellose; Drug: Post-LASIK 0.3% hypromellose	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery
• Actual Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-LASIK 0.3% hypromellose	Drug: 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.
Active Comparator: Post-LASIK 0.3% hypromellose	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Delhi		India	110088

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
• Study Director: Novartis India Ltd., Novartis India Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00909324
• Other Study ID Numbers: CGET980AIN03
• First Posted: May 28, 2009
• Last Update Posted: Aug 17, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Novartis Pharmaceuticals: Post LASIK dry eye; Pre LASIK dry eye; Hypromellose
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Arm/Group Title	Pre-LASIK 0.3% Hypromellose	Post-LASIK 0.3% Hypromellose
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	72	90
COMPLETED	72	90
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pre-LASIK 0.3% Hypromellose	Post-LASIK 0.3% Hypromellose	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	72	90	162
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	26.24 (4.81)	25.99 (5.06)	26.10 (4.93)
Sex: Female, Male (Count of Participants)
Female	50 69.4%	66 73.3%	116 71.6%
Male	22 30.6%	24 26.7%	46 28.4%

Outcome Measures

1. Primary Outcome

Title	Ocular Comfort Level From Baseline to End of Study
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population: All patients in the study who received study treatment.

Arm/Group Title	Pre-LASIK 0.3% Hypromellose	Post-LASIK 0.3% Hypromellose
Arm/Group Description	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.	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.
Measure Participants	72	90
Burning in eyes: Post-LASIK Day 1	0.68 (1.18)	0.84 (1.16)
Burning in eyes: Day 7	0.24 (0.52)	0.31 (0.54)
Burning in eyes: Day 30	0.08 (0.33)	0.07 (0.26)
Foreign body sensation: Post-LASIK Day 1	0.94 (1.47)	1.09 (1.41)
Foreign body sensation: Day 7	0.26 (0.56)	0.27 (0.55)
Foreign body sensation: Day 30	0.05 (0.29)	0.09 (0.33)
Itching: Post-LASIK Day 1	0.35 (0.77)	0.71 (1.21)
Itching: Day 7	0.16 (0.48)	0.32 (0.68)
Itching: Day 30	0.05 (0.22)	0.13 (0.42)
Watering of eyes: Post-LASIK Day 1	0.71 (0.94)	0.71 (0.96)
Watering of eyes: Day 7	0.22 (0.49)	0.25 (0.49)
Watering of eyes: Day 30	0.10 (0.30)	0.09 (0.29)
Dryness of eyes: Post-LASIK Day 1	0.82 (1.18)	1.28 (1.71)
Dryness of eyes: Day 7	0.41 (0.72)	0.72 (0.98)
Dryness of eyes: Day 30	0.25 (0.60)	0.49 (0.84)
Photophobia: Post-LASIK Day 1	0.22 (0.54)	0.41 (0.90)
Photophobia: Day 7	0.09 (0.33)	0.09 (0.37)
Photophobia: Day 30	0.08 (0.33)	0.07 (0.26)

2. Secondary Outcome

Title	Tear Breakup Time From Baseline to End of Study
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population: All patients in the study who received study treatment.

Arm/Group Title	Pre-LASIK 0.3% Hypromellose	Post-LASIK 0.3% Hypromellose
Arm/Group Description	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.	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.
Measure Participants	72	90
Post-LASIK Day 1	14.60 (6.06)	12.47 (6.20)
Day 7	13.47 (6.22)	10.84 (3.58)
Day 30	13.63 (5.36)	12.70 (5.38)

3. Secondary Outcome

Title	Results of Schirmer's Test From Baseline to End of Study
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population: All patients in the study who received study treatment.

Arm/Group Title	Pre-LASIK 0.3% Hypromellose	Post-LASIK 0.3% Hypromellose
Arm/Group Description	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.	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.
Measure Participants	72	90
Left eye: Post-LASIK Day 1	19.64 (8.50)	17.21 (7.10)
Left eye: Day 7	17.68 (9.93)	17.93 (5.43)
Left eye: Day 30	21.70 (13.01)	18.77 (7.11)
Right eye: Post-LASIK Day 1	22.65 (7.10)	13.70 (2.91)
Right eye: Day 7	22.78 (0.49)	15.25 (0.49)
Right eye: Day 30	22.89 (2.47)	18.35 (3.83)

Adverse Events

Arm/Group Title	Pre-LASIK 0.3% Hypromellose		Post-LASIK 0.3% Hypromellose
Arm/Group Description	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.		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.
All Cause Mortality
	Pre-LASIK 0.3% Hypromellose		Post-LASIK 0.3% Hypromellose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-LASIK 0.3% Hypromellose		Post-LASIK 0.3% Hypromellose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/90 (0%)
Other (Not Including Serious) Adverse Events
	Pre-LASIK 0.3% Hypromellose		Post-LASIK 0.3% Hypromellose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/90 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.